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Federal Criminal TrialtranscripttranscriptSunil Dhawan — Cross/Redirect/Recross (Continued) - Day 20 - Federal Criminal TrialSunil Dhawan's testimony concluded with cross-examination about his limited oversight and reliance on Theranos staff, followed by redirect and recross clarifying his assumptions about employees and laboratory records. The court then heard and declined to act immediately on a defense concern that the questioning could imply data falsification.
John C. BosticJeff SchenkLance A. WadeEdward J. DavilaSunil DhawanMr. WadeSunil DhawanMr. SchenkJudge DavilaCourt ClerkMr. Bosticcrossredirectrecrossprocedural
3 pages·2 witnesses·1,248 lines
Sunil Dhawan's testimony concluded with cross-examination about his limited oversight and reliance on Theranos staff, followed by redirect and recross clarifying his assumptions about employees and laboratory records. The court then heard and declined to act immediately on a defense concern that the questioning could imply data falsification.
Proceedings
CrossSunil Dhawan — CrossLine 5
Redirect 1Sunil Dhawan — RedirectLine 1
RecrossSunil Dhawan — RecrossLine 1
Redirect 2Sunil Dhawan — RedirectLine 19
ProceduralHearing on Data-Integrity QuestioningLine 23

CROSS-EXAMINATION (RESUMED) BY MR. WADE:

MR. WADE: GOOD MORNING, DR. DHAWAN.

SUNIL DHAWAN: GOOD MORNING.

MR. WADE: I THINK WHEN WE LEFT OFF WE WERE TALKING A LITTLE BIT ABOUT SOME OF THE INTERACTIONS THAT YOU HAD WITH THERANOS AND I'D LIKE TO PICK UP ON THAT. YOU WERE SHOWN DOCUMENT 2553, WHICH IS IN EVIDENCE. DO YOU STILL HAVE THAT DOCUMENT IN FRONT OF YOU? IT'S THE FIRST DOCUMENT IN THE BLACK BINDER, I BELIEVE.

MR. WADE: AND I'M JUST CALLING YOUR ATTENTION TO THE FIFTH PAGE OF THIS EXHIBIT. I THINK WHEN WE LEFT OFF THIS WAS -- WE WERE TALKING ABOUT THE FACT THAT LYNETTE SAWYER SERVED AS THE CO-LABORATORY DIRECTOR AT THERANOS DURING THIS PERIOD. DO YOU RECALL THAT?

SUNIL DHAWAN: I SEE HER NAME HERE, YES.

MR. WADE: OKAY. AND I'D JUST LIKE TO NOTE NEXT TO THE HOURS WORK SPENT IN THIS DOCUMENT, DO YOU SEE THAT COLUMN UP THERE?

MR. WADE: IT NOTES THAT THE CO-LABORATORY DIRECTORS WERE ONLY GOING TO WORK 1 TO 5 HOURS AS NEEDED; CORRECT?

MR. WADE: AND THERE'S NO SUGGESTION IN THIS DOCUMENT OR ANY SUGGESTION THAT YOU'RE AWARE OF THAT YOU WERE GOING TO BE WORKING FULL TIME ON THIS JOB; RIGHT?

MR. WADE: OKAY. AND I THINK WHEN YOU WERE ON DIRECT EXAMINATION, MR. SCHENK ASKS YOU SOME QUESTIONS ABOUT THIS PERIOD BETWEEN NOVEMBER AND JULY AND NOTED THAT YOU HADN'T REALLY DONE MUCH ON AN AS-NEEDED BASIS FOR THERANOS. DO YOU RECALL THAT?

MR. WADE: AND DO YOU KNOW IF THAT'S BECAUSE WHEN THERE WERE SERVICES THAT WERE NEEDED IN THIS PERIOD, THAT THEY WERE CALLING ON MS. SAWYER TO DO THOSE SERVICES?

SUNIL DHAWAN: I DON'T KNOW WHO THEY WERE CALLING.

MR. WADE: OKAY. BUT THEY WEREN'T CALLING YOU?

MR. WADE: RIGHT. LET'S GO TO 10566 AND JUST FLESH OUT THIS CHRONOLOGY A LITTLE BIT. IT'S IN THAT SAME BOOK. DO YOU HAVE THAT IN FRONT OF YOU, DOCTOR?

MR. WADE: OKAY. DO YOU SEE 10566, IF YOU WOULD LOOK AT A COUPLE OF PAGES, DO YOU RECOGNIZE THIS TO BE THE PAPERWORK RELATING TO YOUR GOING ON TO THE CLIA LICENSE AT THERANOS?

MR. WADE: I WOULD MOVE THE ADMISSION OF 10566.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10566 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND IF WE COULD JUST GO TO THE SECOND PAGE. DO YOU SEE THAT THIS WAS FROM DOCTOR -- THIS WAS A LETTER THAT WAS SENT TO THE REGULATORS FROM BRAD ARINGTON. DO YOU SEE THAT?

MR. WADE: AND THAT WAS THE SENIOR REGULATORY COUNSEL AT THERANOS WHO YOU WERE DEALING WITH WHEN YOU WERE SIGNING UP WITH THE COMPANY. DO YOU RECALL THAT?

MR. WADE: OKAY. AND HE SENT IN THIS PAPERWORK, AND JUST FOCUSSING ON THE SECOND PAGE, THIS NOTES THAT YOU WENT ON TO THE LICENSE NOVEMBER 19TH, 2014. DO YOU SEE THAT?

MR. WADE: AND DO YOU RECALL AT THE TIME WHEN YOU INITIALLY WENT ON THE LICENSE THAT DR. ROSENDORFF WAS STILL ON THE LICENSE FOR ABOUT A MONTH AS WELL?

SUNIL DHAWAN: I DON'T RECALL THAT THAT WAS HAPPENING.

MR. WADE: OKAY. WELL, LET'S LOOK AT 10567. YOUR HONOR, I BELIEVE THIS IS A PUBLIC RECORD. I WOULD MOVE THE ADMISSION OF 10567.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10567 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND DO YOU SEE, DOCTOR, THIS IS A LETTER FROM DR. ROSENDORFF IN WHICH HE WAS REMOVING HIMSELF FROM THE CLIA LICENSE DECEMBER 17TH, 2014?

MR. WADE: OKAY. AND SO AT THAT POINT, HE WAS NO LONGER GOING TO BE SERVING AS THE CO-LABORATORY DIRECTOR WITH YOU?

SUNIL DHAWAN: ACCORDING TO THIS PAPERWORK, YES.

MR. WADE: OKAY. ARE YOU AWARE ON ABOUT THAT SAME DATE THAT MS. SAWYER WAS ADDED TO THE LICENSE?

SUNIL DHAWAN: I DON'T SEE THAT HERE.

MR. WADE: OKAY. I'LL TURN YOUR ATTENTION TO 10562. DO YOU HAVE THAT IN FRONT OF YOU, DOCTOR?

MR. WADE: AND THIS IS A PUBLIC RECORD, SO I WOULD MOVE THE ADMISSION OF 10562.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10562 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND DO YOU SEE THIS IS A LETTER I THINK THE SAME DAY OR MAYBE THE NEXT DAY AFTER DR. ROSENDORFF WENT OFF THE LICENSE?

MR. WADE: AND DO YOU SEE, IF YOU TURN TO THE SECOND PAGE, THAT THIS IS PAPERWORK THAT SHOWS THAT DR. SAWYER WAS GOING ON TO THE LICENSE?

MR. WADE: AND IT WAS ACTUALLY EFFECTIVE AS OF NOVEMBER 19TH, 2014. DO YOU SEE THAT?

MR. WADE: OKAY. SO ACCORDING TO THIS PAPERWORK, SHE SERVED AS THE CO-LABORATORY DIRECTOR AT THERANOS; CORRECT?

MR. WADE: OKAY. AND YOU RECALL THAT WE SAW THAT ONE OF THOSE POLICIES -- AND AGAIN, SHE WAS SERVING, ACCORDING TO THE RECORD WE LOOKED AT BEFORE, IN A SIMILAR PART-TIME CAPACITY AS YOU WERE ON AN AS-NEEDED BASIS; CORRECT?

MR. WADE: AND DO YOU RECALL YESTERDAY WE SAW ONE OF THE POLICIES FROM THAT PERIOD BETWEEN NOVEMBER AND AUGUST WHERE DR. SAWYER SIGNED ONE OF THE SOP'S?

MR. WADE: LET'S GO TO ANOTHER ONE, 10525. DO YOU HAVE THAT IN FRONT OF YOU?

MR. WADE: AND DO YOU RECOGNIZE THIS AS A VERIFICATION DOCUMENT WHEN THEY WERE BRINGING AN ASSAY ON TO A SIEMENS ADVIA 2400?

SUNIL DHAWAN: THAT'S WHAT IT APPEARS TO BE, YES.

MR. WADE: AND YOU SEE DR. SAWYER'S SIGNATURE DOWN THERE ON THE BOTTOM (INDICATING)?

MR. WADE: I MOVE THE ADMISSION OF 10525.

MR. SCHENK: FOUNDATION.

JUDGE DAVILA: DO YOU WANT TO LAY A LITTLE MORE FOUNDATION, COUNSEL?

BY MR. WADE:

MR. WADE: YOU UNDERSTAND THAT WHEN TESTS ARE BROUGHT ONTO LINE, OR BROUGHT ONLINE WITHIN A LAB, THAT THERE ARE REGULATIONS WHERE THE LAB DIRECTOR VERIFIES THAT IT'S APPROPRIATE TO BRING THE TEST ONLINE?

MR. WADE: AND THAT EITHER LAB DIRECTOR CAN ATTEST TO THAT VERIFICATION AND CERTIFY THAT IT'S APPROPRIATE FOR THE TEST TO BE OFFERED WITHIN THE LAB?

MR. WADE: AND THAT -- AND YOUR CO-LABORATORY DIRECTOR, DR. SAWYER, WOULD HAVE HAD THE ABILITY UNDER THE LAW TO, TO SERVE THAT FUNCTION; CORRECT?

SUNIL DHAWAN: IF THAT'S WHAT THE LAW STATES, YES.

MR. WADE: AND WHEN THAT'S DONE, THESE RECORDS WOULD BE MAINTAINED WITHIN THE CLIA LAB SO IF THERE ARE EVER ANY QUESTIONS ABOUT WHETHER -- WHEN A TEST WAS VERIFIED, THERE WOULD BE DOCUMENTATION OF THAT; CORRECT?

MR. WADE: OKAY. I WOULD MOVE THE ADMISSION OF 10525.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10525 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND YOU HAD MENTIONED THAT YOU SAW A SIEMENS ADVIA WHEN YOU TOURED THE COMPANY. DO YOU RECALL THAT?

MR. WADE: AND THAT'S ONE OF THE DEVICES THAT MR. BALWANI AND OTHERS IN THE LAB SHOWED YOU?

MR. WADE: OKAY. AND YOU UNDERSTOOD THAT THE COMPANY WAS USING SIEMENS ADVIA EQUIPMENT?

SUNIL DHAWAN: YES, I SEE THAT THERE.

MR. WADE: OKAY. I JUST WANT TO FOCUS YOUR ATTENTION ON THE BOTTOM. AND DR. SAWYER -- BY THIS SIGNATURE, DR. SAWYER IS VERIFYING THE APPROPRIATENESS OF USING THIS ASSAY IN THE THERANOS CLINICAL LAB AS OF JANUARY 11TH, 2015; CORRECT?

MR. WADE: OKAY. AND IF I CAN DRAW YOUR ATTENTION TO EXHIBIT 10526. DO YOU HAVE THAT IN FRONT OF YOU?

MR. WADE: AND YOU UNDERSTAND THAT, FROM YOUR EXPERIENCE WITH YOUR OWN LAB AND OTHERWISE, THAT WHEN TESTS ARE OFFERED IN A LAB, STANDARD OPERATING PROCEDURES ARE CREATED?

MR. WADE: AND THOSE PROCEDURES SET FORTH A MANNER BY WHICH A TEST SHOULD BE PERFORMED WITHIN THE LAB?

MR. WADE: AND THAT IT'S IMPORTANT TO DOCUMENT THAT STANDARD PROCEDURE AND SIGN OFF ON IT SO THERE'S A RECORD IF ANYONE EVER ASKS QUESTIONS ABOUT IT?

MR. WADE: OKAY. AND DO YOU RECOGNIZE 10526 TO BE SUCH A RECORD?

SUNIL DHAWAN: IT STATES THAT IT'S -- YEAH, STANDARD OPERATING PROCEDURE, YES.

MR. WADE: OKAY. I MOVE THE ADMISSION OF 10526.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10526 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND THIS IS ONE OF THOSE STANDARD OPERATING PROCEDURES; CORRECT?

MR. WADE: OKAY. AND YOU SEE THERE THAT DR. SAWYER SIGNED OFF ON THIS DOCUMENT LATE MARCH 2015? DO YOU SEE THAT?

MR. WADE: AND YOU ALSO SEE THAT THERE ARE A NUMBER OF OTHER PEOPLE WHO HAD WORKED ON THIS PROCEDURE WHO ALSO SIGNED OFF; CORRECT?

MR. WADE: AND THOSE ARE PEOPLE WHO HAVE DIFFERENT CLIA LICENSES OR CERTIFICATIONS AS NOTED IN THEIR TITLES?

MR. WADE: AND JUST SO WE'RE CLEAR, THERE'S NOT A REQUIREMENT THAT BOTH LAB DIRECTORS SIGN OFF ON DOCUMENTS; CORRECT? IT ONLY REQUIRES ONE LAB DIRECTOR TO SIGN OFF ON DOCUMENTS; CORRECT?

SUNIL DHAWAN: AS FAR AS I'M AWARE OF, YES.

MR. WADE: YEAH. AND I TAKE IT, SIR, THERE WAS NOTHING THAT MADE YOU UNCOMFORTABLE ABOUT THE FACT THAT THERANOS HAPPENED TO ASK DR. SAWYER TO SIGN OFF ON THESE DURING THIS PERIOD RATHER THAN YOU? THAT DIDN'T UPSET YOU, DID IT?

SUNIL DHAWAN: I WAS NEVER AWARE THAT SHE WAS SIGNING OFF ON ALL OF THESE.

MR. WADE: RIGHT. BUT -- AND AS BEST YOU CAN TELL, SHE FILED THE APPROPRIATE PAPERWORK WITH CLIA; CORRECT?

MR. SCHENK: OBJECTION. CALLS FOR SPECULATION.

SUNIL DHAWAN: I DON'T -- I --

JUDGE DAVILA: EXCUSE ME FOR JUST A SECOND. IF YOU WANT TO LAY A FOUNDATION.

MR. WADE: YOU SAW THE PAPERWORK WHERE DR. SAWYER SIGNED THE PAPERWORK TO BECOME A LAB DIRECTOR AT THERANOS; CORRECT?

SUNIL DHAWAN: WHAT I JUST SAW, YES.

MR. WADE: AND THE FACT THAT SHE WAS ACTING AS THE LABORATORY DIRECTOR ON THERANOS SIGNED DOCUMENTS, THAT DOESN'T GIVE YOU ANY CONCERN, DOES IT?

SUNIL DHAWAN: I CAN'T GIVE YOU AN OPINION. I MEAN, IF SHE'S CERTIFIED, IF SHE'S A PH.D., THEN SHE'S ALLOWED TO BE A LAB DIRECTOR. BUT I CAN'T VERIFY THAT SHE IS OR ISN'T.

MR. WADE: RIGHT. I UNDERSTAND. BUT PUT DIFFERENTLY --

MR. WADE: -- IN THIS PERIOD WHERE THE GOVERNMENT WAS FOCUSSED ON WHERE YOU WERE NOT ACTING AS THE LABORATORY DIRECTOR, IT APPEARS THAT THERE WAS SOMEONE ELSE ACTING AS THE LABORATORY DIRECTOR AT THERANOS; CORRECT?

SUNIL DHAWAN: BASED ON THE SIGNATURES. THAT'S ALL I CAN TELL YOU.

MR. WADE: SURE. I UNDERSTAND. AND LET'S GO TO 10529. DO YOU HAVE THAT DOCUMENT IN FRONT OF YOU, DOCTOR?

MR. WADE: AND DO YOU RECOGNIZE THIS TO BE AN EMAIL FROM LANGLY GEE TO YOU?

MR. WADE: AND THIS RELATES TO SOME REGULATORY PAPERWORK RELATING TO THERANOS LAB?

MR. WADE: OKAY. I WOULD MOVE THE ADMISSION OF 10529.

MR. SCHENK: YOUR HONOR, I THINK THIS IS IN EVIDENCE.

JUDGE DAVILA: LET'S SEE. MS. KRATZMANN?

MR. SCHENK: I THINK IT'S 2972.

COURT CLERK: WHAT WAS THAT NUMBER, COUNSEL?

MR. SCHENK: I'M SORRY, THAT'S NOT THE RIGHT NUMBER. YOUR HONOR, NO OBJECTION. I'M NOT SURE THIS IS IN OR NOT.

MR. WADE: I THINK IT'S A DIFFERENT DOCUMENT, JEFF.

JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10529 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: NOW, THIS IS AN EMAIL FROM LANGLY GEE. DO YOU SEE THAT?

MR. WADE: AND YOU UNDERSTOOD THAT LANGLY GEE WAS THE FULL-TIME QUALITY CONTROL AND QUALITY ASSURANCE MANAGER AT THERANOS?

MR. WADE: AND DO YOU RECALL, I BELIEVE MR. SCHENK SHOWED YOU A DOCUMENT YESTERDAY, IN THE SAME TIME PERIOD WHERE MR. GEE TOLD YOU THAT HE WAS GOING TO SEND YOU A FEW HUNDRED SOP'S TO REVIEW. DO YOU RECALL THAT?

MR. WADE: AND THERE'S ANOTHER EMAIL THAT I DON'T THINK MR. SCHENK SHOWED YOU -- MAYBE IT WILL REFRESH YOUR RECOLLECTION -- THAT YOU RESPONDED AND ASKED THAT HE SEND ABOUT 50 A WEEK SO YOU CAN SPACE YOUR REVIEW OUT OVER TIME. DO YOU RECALL THAT?

MR. WADE: AND THIS, I BELIEVE, WAS ONE OF THE FIRST PERIODS WHERE YOU WERE BEING ASKED TO REVIEW POLICIES; CORRECT?

MR. WADE: OKAY. AND I BELIEVE IT'S THE -- WITHIN A DAY OR TWO MR. GEE SENDS YOU THIS DOCUMENT. AND DO YOU SEE THAT THIS DOCUMENT NOTES THAT MS. SAWYER WAS COMING OFF OF THE CLIA LICENSE IN THIS PERIOD AND THERE WAS SOME PAPERWORK NEEDED IN CONNECTION WITH THAT?

MR. WADE: AND DOES THIS REFRESH YOUR RECOLLECTION THAT PART OF THE REASON WHY YOU WEREN'T CALLED UPON TO REVIEW POLICIES AND PROCEDURES UNTIL AUGUST WAS BECAUSE MS. SAWYER HAD SERVED THAT FUNCTION PRIOR TO THEN?

SUNIL DHAWAN: I WAS NEVER MADE AWARE THAT SHE WAS DOING THAT PREVIOUSLY.

MR. WADE: ALL RIGHT. WITHIN THIS DOCUMENT, YOU UNDERSTOOD THAT SHE HAD PREVIOUSLY BEEN ON -- AS THE LAB DIRECTOR AND SHE WAS BEING REMOVED AT THIS POINT; RIGHT?

SUNIL DHAWAN: THAT'S -- YEAH, THAT'S WHAT IT SAYS.

MR. WADE: AND THAT HAPPENS TO COINCIDE WITH THE TIME WHERE YOU'RE NOW ASKED TO REVIEW POLICIES; CORRECT?

MR. WADE: OKAY. AND IF YOU JUST -- IF WE LOOK AT THE NEXT PAGE, WE SEE -- I THINK WE HAD -- THERE WAS A VERSION OF THIS BEFORE WE LOOKED AT WHERE SHE WAS IDENTIFIED; CORRECT?

MR. WADE: BUT NOW THIS VERSION OF THE ROSTER, THE LABORATORY PERSONNEL REPORT, NOW REMOVES HER FROM THAT; CORRECT?

MR. WADE: AND SO -- AND IN THIS TIME THEN, YOU'RE ASKED TO TAKE ON A LITTLE MORE RESPONSIBILITY; CORRECT?

MR. WADE: OKAY. AND THAT'S NOTED IN MR. GEE'S EMAIL IN THE FIRST PAGE WHERE HE SAYS HE'S GOING TO START SENDING YOU 50 SOP'S PER WEEK. DO YOU SEE THAT?

MR. WADE: AND DO YOU UNDERSTAND THAT PART OF THE REASON WHY THESE SOP'S WERE BEING SENT TO YOU WAS BECAUSE THE COMPANY WAS GETTING ALL OF THEIR PAPERWORK IN ORDER BECAUSE THEY KNEW THAT THE CLIA AUDIT WAS COMING UP AND THEY WANTED ALL OF THE I'S DOTTED AND THE T'S CROSSED?

MR. WADE: OKAY. AND YOU DIDN'T WANT ALL OF THOSE POLICIES AT ONE TIME; CORRECT?

MR. WADE: YOU WANTED TO HAVE A LITTLE MORE TIME TO SPACE OUT YOUR REVIEW OF THOSE DOCUMENTS; ISN'T THAT RIGHT?

MR. WADE: AND MR. GEE SAYS THAT HE'LL SEND YOU 50 A WEEK; IS THAT RIGHT?

MR. WADE: AND IF WE GO TO THE SECOND PAGE OF THIS EXHIBIT, THIS DOCUMENT IDENTIFIES CLIA PERSONNEL WHO WORK WITHIN THE LAB; CORRECT?

MR. WADE: AND JUST SO WE'RE CLEAR, AT THE POINT THAT YOU WERE SERVING IN THIS AS-NEEDED ROLE FOR THE LAB, THE LAB WAS PRETTY WELL ESTABLISHED AT THIS POINT; CORRECT?

SUNIL DHAWAN: THAT WOULD BE MY ASSUMPTION, YES.

MR. WADE: YEAH. I MEAN, YOU UNDERSTOOD THAT THEY HAD HAD A LONG-TIME LAB DIRECTOR IN DR. ROSENDORFF PREVIOUSLY?

MR. WADE: AND MR. SCHENK SHOWED YOU A LOT OF THE DOCUMENTS WHERE YOU REVIEWED HIS WORK ESSENTIALLY. DO YOU RECALL THAT?

MR. WADE: AND WE'LL LOOK AT SOME OF THOSE DOCUMENTS, BUT AS A GENERAL MATTER, DID THE ROSTER OF PEOPLE AND THE FACT THAT THERE WAS THIS LAB DIRECTOR PREVIOUSLY GIVE YOU COMFORT AS TO THE MATERIALS THAT YOU WERE SIGNING OFF ON?

SUNIL DHAWAN: YES. YOU'RE DEPENDENT ON THE PEOPLE WHO ARE WORKING ON THESE DOCUMENTS.

MR. WADE: AND, IN FACT, SIR, YOU'RE SPECIFICALLY AUTHORIZED TO DEPEND ON THOSE PEOPLE WHEN YOU SERVE AS A LABORATORY DIRECTOR; CORRECT?

SUNIL DHAWAN: IF THAT'S IN THE STATUTE, YES.

MR. WADE: YEAH, LET'S TAKE A LOOK AT THAT. IF WE CAN GO TO 7603, AND THIS IS A BIG DOCUMENT, SO WE'LL PUT UP ON THE SCREEN THE RELEVANT PORTION. IT'S IN EVIDENCE. YOU'RE WELCOME TO LOOK AT ANY PORTION, BUT I WANT TO DRAW YOUR ATTENTION TO 1445. DO YOU SEE THAT? IT'S ON THE SCREEN. IT'S ACTUALLY ON THE SCREEN. IF WE CAN JUST HIGHLIGHT (C) AND (D) JUST SO IT'S A LITTLE BIT BIGGER. DO YOU SEE THAT, DOCTOR?

MR. WADE: OKAY. AND THIS NOTES THAT YOU HAVE TO BE ACCESSIBLE TO THE LABORATORY TO PROVIDE ON SITE TELEPHONE OR ELECTRONIC CONSULTATION AS NEEDED; RIGHT?

MR. WADE: AND YOU WERE SO AVAILABLE; CORRECT?

MR. WADE: AND THEN IT SAYS, "EACH INDIVIDUAL MAY DIRECT NO MORE THAN FIVE LABORATORIES." DO YOU SEE THAT?

MR. WADE: AND THAT MEANS THAT YOU COULD -- IT'S OKAY TO SERVE, UNDER THE REGULATIONS, AS A PART-TIME LAB DIRECTOR?

SUNIL DHAWAN: BASED ON WHAT (D) SAYS, YES.

MR. WADE: AND YOU WERE A LAB DIRECTOR OF YOUR OWN LAB, BUT YOU WERE JUST A LAB DIRECTOR OF TWO LABS; CORRECT?

MR. WADE: OKAY. AND WHEN YOU'RE NOT A FULL-TIME LAB DIRECTOR, YOU HAVE TO RELY UPON SOME PEOPLE TO PERFORM SOME OF THE DAY-TO-DAY FUNCTIONS; CORRECT?

MR. WADE: BECAUSE NO ONE WAS PRETENDING THAT YOU WERE THERE EACH AND EVERY DAY; RIGHT? YOU WERE THERE AS NEEDED; CORRECT?

SUNIL DHAWAN: THAT'S WHAT I WAS ASKED TO DO, YES.

MR. WADE: RIGHT, RIGHT. AND THAT'S WHAT THIS REGULATION ALLOWS; CORRECT?

MR. WADE: AND DO YOU RECALL THAT AS A RESULT OF THAT, THAT YOU PREPARED SOME FORMAL WRITTEN DELEGATIONS WHERE YOU FORMALLY DELEGATED TASKS -- OR YOU SIGNED OFF ON FORMAL DELEGATIONS WHERE YOU FORMALLY DELEGATED TASKS TO SOME OF THESE OTHER FULL-TIME EMPLOYEES WITHIN THE CLIA LAB?

SUNIL DHAWAN: I'D HAVE TO REVIEW THOSE, BUT --

MR. WADE: WHY DON'T WE PULL ONE UP. LET'S LOOK AT 10577. DO YOU HAVE THAT IN FRONT OF YOU, DOCTOR?

MR. WADE: AND DO YOU SEE THAT 10577 IS A FORMAL WRITTEN DELEGATION WHERE YOU'RE DELEGATING DAY-TO-DAY RESPONSIBILITIES TO FULL-TIME EMPLOYEES WITHIN THE LABORATORY?

MR. WADE: OKAY. I MOVE THE ADMISSION OF 10577.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10577 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: OKAY. AND THIS DOCUMENT ASSIGNS CERTAIN DAY-TO-DAY RESPONSIBILITIES. IF WE CAN -- WELL, FIRST OF ALL, IT SETS FORTH THE MINIMUM QUALIFICATIONS NEEDED FOR SOMEONE TO SERVE AS THE TECHNICAL SUPERVISOR; CORRECT?

MR. WADE: AND THAT WAS IMPORTANT BECAUSE YOU NEEDED TO MAKE SURE THAT THEY MET THE REGULATORY STANDARDS; ISN'T THAT RIGHT?

MR. WADE: OKAY. AND IF WE GO TO THE DUTIES AND RESPONSIBILITIES, HERE THERE'S A FORMAL WRITTEN DELEGATION OF THOSE RESPONSIBILITIES TO MS. ALAMDAR. DO YOU REMEMBER MS. ALAMDAR?

SUNIL DHAWAN: YES, I MET HER.

MR. WADE: YEAH. AND SHE WAS AN EXPERIENCED LAB PERSON. DO YOU RECALL THAT?

SUNIL DHAWAN: I DON'T HAVE HER CV IN FRONT OF ME, BUT I RECALL THAT SHE WASN'T -- THAT THIS WAS HER POSITION, YES.

MR. WADE: AND SHE WAS VERY INVOLVED IN THE ACTIVE DAY-TO-DAY MANAGEMENT OF THE LABORATORY; CORRECT?

SUNIL DHAWAN: THAT'S MY ASSUMPTION, YES.

MR. WADE: AND BY THIS DOCUMENT, SHE'S DELEGATED A LOT OF THOSE DAY-TO-DAY RESPONSIBILITIES; CORRECT?

MR. WADE: AND DO YOU SEE, FOR EXAMPLE, NUMBER 1 DELEGATES TO HER THAT SHE'S RESPONSIBLE FOR PROVIDING DAY-TO-DAY SUPERVISION OF THE HIGH COMPLEXITY TEST PERFORMANCE BY TESTING PERSONNEL. DO YOU SEE THAT?

MR. WADE: AND THEN THERE ARE A NUMBER OF OTHER OBLIGATIONS THAT ARE DELEGATED TO HER; CORRECT?

MR. WADE: AND AS A PART-TIME LAB DIRECTOR, IT'S NECESSARY FOR YOU TO DO THIS BECAUSE YOU CAN'T BE THERE EVERY DAY AND PERFORM THESE FUNCTIONS; CORRECT?

MR. WADE: OKAY. AND LET'S GO TO 10578. DO YOU HAVE THAT DOCUMENT IN FRONT OF YOU, DOCTOR?

MR. WADE: AND THIS IS ANOTHER DELEGATION, FORMAL WRITTEN DELEGATION OF RESPONSIBILITIES TO ANOTHER FORMAL -- ANOTHER FULL-TIME LAB EMPLOYEE AT THERANOS; CORRECT?

MR. WADE: MOVE THE ADMISSION OF 10578.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10578 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND THE GENERAL SUPERVISOR IS ACTUALLY A PRETTY SENIOR POSITION WITHIN THE LAB; CORRECT?

MR. WADE: AND THIS WAS DELEGATED -- IT'S A LITTLE HARD TO READ THE PRINT -- TO MR. GODFRED MASINDE?

SUNIL DHAWAN: I MET HIM, YES.

MR. WADE: AND HE ASSUMED CERTAIN DAY-TO-DAY RESPONSIBILITIES TO ENSURE THAT THE CLIA OBLIGATIONS WERE MET; CORRECT?

MR. WADE: OKAY. AND THOSE ARE SET FORTH WITHIN THE NUMBERED ITEMS IN THIS DOCUMENT; IS THAT RIGHT?

MR. WADE: AND YOU SIGNED OFF ON THIS DOCUMENT INFORMALLY DELEGATING THOSE RESPONSIBILITIES TO HIM; CORRECT?

MR. WADE: AND LET'S GO BACK BRIEFLY TO EXHIBIT 2553, WHICH I THINK IS THE FIRST DOCUMENT. IF WE CAN JUST GO TO PAGE 10 OF THE EXHIBIT, I'M SORRY, PAGE 11 OF THE EXHIBIT. AND THE ROSTER OF PEOPLE, WE'VE TALKED ABOUT THESE A COUPLE OF TIMES. DO YOU RECALL?

MR. WADE: AND THE PEOPLE WHO YOU FORMERLY DELEGATED RESPONSIBILITIES TO, AS A PART-TIME LAB DIRECTOR, YOU WERE DEPENDING ON THESE PEOPLE TO PERFORM THEIR FUNCTIONS AS WELL; CORRECT?

MR. WADE: AND THIS ROSTER OF PEOPLE, THAT'S A PRETTY LONG ROSTER OF PEOPLE WHO ARE INVOLVED IN RUNNING THE LAB ON A FULL-TIME BASIS; ISN'T IT?

SUNIL DHAWAN: THERE'S A LOT OF NAMES ON THIS LIST, YES.

MR. WADE: RIGHT. AND A LOT OF PEOPLE WORKING FULL TIME WITHIN THE LAB; CORRECT?

SUNIL DHAWAN: I ASSUME THEY ARE, YES.

MR. WADE: WELL, YOU SAW SOME OF THEM WHEN YOU WERE THERE FOR YOUR VISIT; RIGHT?

SUNIL DHAWAN: YES, YES.

MR. WADE: AND IT WAS A BUSY PLACE?

SUNIL DHAWAN: YES, THERE WERE LOTS OF PEOPLE.

MR. WADE: AND IN ADDITION TO THIS, YOU UNDERSTOOD MR. BALWANI WAS VERY ACTIVE IN THE MANAGEMENT OF THE LAB; CORRECT?

SUNIL DHAWAN: THAT WAS MY UNDERSTANDING.

MR. WADE: HE WAS THE PERSON WHO HIRED AND FIRED PEOPLE AND HELPED WITH PROCESSES; CORRECT?

SUNIL DHAWAN: THAT WAS MY UNDERSTANDING, YES.

MR. WADE: AND HE WAS A VERY SENIOR OFFICER WITHIN THE COMPANY. I THINK WE TALKED ABOUT YESTERDAY; CORRECT?

SUNIL DHAWAN: YES, THAT'S MY UNDERSTANDING.

MR. WADE: OKAY. AND DO YOU RECALL YESTERDAY -- I BELIEVE ON THE FLOOR THERE THERE'S A BIG BLACK BINDER. IT'S SOMEWHAT DAUNTING. BUT MR. SCHENK ASKED YOU A COUPLE OF QUESTIONS ABOUT THE VALIDATION REPORTS WITHIN THAT. DO YOU RECALL THAT?

MR. WADE: AND YOU HAD SIGNED, YOU HAD SIGNED OFF ON THOSE VALIDATION REPORTS, CORRECT, WITH THE EXCEPTION OF ONE, I BELIEVE.

MR. WADE: OKAY. AND LET'S, LET'S TAKE A LOOK. I THINK MR. SCHENK SHOWED YOU I BELIEVE IT WAS 9387, WHICH IS TOWARD THE BACK.

MR. WADE: AND MR. -- THIS IS A VALIDATION REPORT FOR THE TPSA ELISA ASSAY ON THE EDISON 3.X THERANOS SYSTEM. DO YOU SEE THAT?

MR. WADE: AND THIS IS ONE OF THOSE INSTANCES WHERE YOU SEE YOU WERE REVIEWING SOMETHING THAT FOUR PEOPLE HAD PREVIOUSLY SIGNED OFF ON; CORRECT?

MR. WADE: AND THREE OF WHOM WERE PH.D.'S?

MR. WADE: AND YOU UNDERSTOOD THAT THESE WERE ALL FULL-TIME EMPLOYEES AT THERANOS?

SUNIL DHAWAN: THAT'S WHAT WOULD -- THAT'S WHAT I ASSUMED, YES.

MR. WADE: AND THEY HAD SPENT A LOT OF TIME WORKING ON THIS; CORRECT?

SUNIL DHAWAN: I DON'T KNOW HOW MUCH TIME THEY SPENT ON IT, BUT I WOULD THINK SO, YEAH.

MR. WADE: WELL, YOU SEE A LOT OF DATA AND INFORMATION?

SUNIL DHAWAN: YEAH, YEAH, SO I WOULD ASSUME, YES.

MR. WADE: AND YOU WERE ESSENTIALLY UPDATING THAT YOU HAD REVIEWED THE DOCUMENT AS WELL, BUT YOU WERE RELYING UPON THEIR WORK; IS THAT RIGHT?

MR. WADE: OKAY. AND TO THE BEST OF YOUR KNOWLEDGE, THERE'S ACTUALLY NO REQUIREMENT THAT YOU HAVE TO SIGN OFF AGAIN ON VALIDATION REPORTS ONCE THEY'RE PUT WITHIN THE LAB, IS THERE?

SUNIL DHAWAN: I'D HAVE TO REVIEW THE STATUTE, BUT I DON'T BELIEVE THERE IS.

MR. WADE: YEAH. AND MAYBE THIS WAS JUST DEEMED A GOOD PRACTICE, SINCE YOU WERE COMING IN, TO HAVE YOU LOOK OVER EVERYTHING?

SUNIL DHAWAN: IT'S ALWAYS A GOOD PRACTICE TO SIGN AND REVIEW.

MR. WADE: YOU WERE HAPPY TO LOOK AT THESE WHEN THEY SHOWED THEM TO YOU?

SUNIL DHAWAN: I WAS GIVEN THAT JOB, AND YES.

MR. WADE: AND YOU ACCEPTED IT?

SUNIL DHAWAN: I DID IT.

MR. WADE: SO IT WAS A GOOD PRACTICE, BUT IT WASN'T A LEGAL REQUIREMENT OR ANYTHING?

SUNIL DHAWAN: IF IT'S NOT IN THE STATUTE, YEAH.

MR. WADE: AND YOU HAVE NEVER SEEN A STATUTE THAT WOULD REQUIRE IT?

MR. WADE: AND WITH RESPECT TO SOME OF THESE, I DON'T KNOW IF YOU RECALL, BUT SOME OF THEM HAD AS MANY AS, YOU KNOW, NINE OR TEN PEOPLE WHO SIGNED OFF ON THOSE. AND IS IT FAIR TO SAY, IF I WENT THROUGH AND ASKED YOU QUESTIONS ABOUT THAT, YOU WERE RELYING UPON THE GOOD WORK OF THOSE PEOPLE WHO HAD DOCUMENTED ALL OF THIS WORK PREVIOUSLY; CORRECT?

MR. WADE: AND YOU DIDN'T HAVE ANY REASON TO NOT -- TO THINK THAT WORK WAS UNRELIABLE; CORRECT?

SUNIL DHAWAN: NOTHING -- NO. NO.

MR. WADE: OKAY. AND THIS PARTICULAR REPORT, THE 9387, THAT'S FOR THE EDISON -- THAT'S FOR THE EDISON DEVICE. DO YOU SEE THAT?

MR. WADE: AND MR. SCHENK ASKED YOU SOME QUESTIONS ABOUT THE EDISON DEVICE. DO YOU RECALL THAT?

MR. WADE: AND AGAIN, YOUR INTERACTIONS WITH THE COMPANY REALLY INCREASED IN AUGUST AFTER MS. SAWYER LEFT; CORRECT?

MR. WADE: OKAY. AND I DON'T THINK MR. SCHENK WENT THROUGH THIS, BUT ARE YOU AWARE THAT AS OF AUGUST OF 2015, THERANOS WAS ACTUALLY NOT RUNNING ANY TESTS ON THE THERANOS DEVICE, ON THE EDISON DEVICE?

SUNIL DHAWAN: I FOUND THAT OUT LATER, BUT, YES, I DIDN'T -- I WASN'T AWARE THAT THEY WEREN'T RUNNING IT AT THAT TIME.

MR. WADE: SO AT THE TIME THAT YOU'RE COMING IN IN AUGUST, THEY'RE NOT RUNNING A SINGLE TEST ON THE EDISON DEVICE; CORRECT?

SUNIL DHAWAN: THAT'S, THAT'S WHAT WAS -- THAT'S WHAT I'VE BEEN TOLD, YEAH. BUT I WAS NOT TOLD THAT AT THAT TIME.

MR. WADE: WELL, LET'S LOOK AT EXHIBIT 4533, WHICH I'LL HAND UP. MAY I APPROACH, YOUR HONOR?

MR. WADE: (HANDING.)

MR. WADE: LET ME KNOW ONCE YOU'VE HAD A CHANCE TO REVIEW THAT, DOCTOR.

(PAUSE IN PROCEEDINGS.)

BY MR. WADE:

MR. WADE: OKAY. AND DOES THIS REFRESH YOUR RECOLLECTION THAT THERANOS ACTUALLY, AT THE TIME THAT YOU ENGAGED IN AUGUST OF 2015, WASN'T RUNNING ANY TESTS ON THE EDISON DEVICE?

SUNIL DHAWAN: ACCORDING TO THIS, YOU KNOW, ACCORDING TO THESE DOCUMENTS, YES.

MR. WADE: I MOVE THE ADMISSION OF 4533.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.

(GOVERNMENT'S EXHIBIT 4533 WAS RECEIVED IN EVIDENCE.)

MR. WADE: AND IF WE CAN BLOW UP THE BOX IN THE BOTTOM.

MR. WADE: ACTUALLY, WE SHOULD LOOK AT THE DATE FIRST. DO YOU SEE THAT THIS IS DATED SEPTEMBER 23RD, 2015; CORRECT?

MR. WADE: AND THIS IS JUST A SHORT TIME, WITHIN A COUPLE OF DAYS OF THAT CMS INSPECTION. DO YOU RECALL THAT?

MR. WADE: OKAY. AND IF YOU LOOK AT THE BOTTOM, THIS IDENTIFIES WHEN TESTS WERE FIRST RUN ON -- WHEN PARTICULAR ASSAYS WERE FIRST RUN ON THE EDISON DEVICE AND WHEN THEY ENDED; CORRECT?

MR. WADE: AND THE LAST DATES IDENTIFIED THERE ARE JUNE 25TH, 2015; CORRECT?

MR. WADE: AND THAT WAS BEFORE YOU ENGAGED ACTIVELY WITH THE COMPANY AFTER DR. SAWYER LEFT; CORRECT?

MR. WADE: OKAY. SO THERE WOULDN'T NECESSARILY EVEN HAVE BEEN A REASON FOR MR. BALWANI OR OTHERS TO SHOW YOU THE EDISON DEVICE ON THE TOUR; ISN'T THAT RIGHT?

SUNIL DHAWAN: I CAN'T COMMENT. I MEAN, YOU'LL HAVE TO MAKE THAT ASSUMPTION. YOU KNOW, I'M NOT SURE I CAN MAKE THAT COMMENT.

MR. WADE: WELL, YOU DIDN'T ASK -- LET ME ASK THIS: YOU DIDN'T ASK THEM TO SHOW YOU THE OTHER DEVICES THAT THEY WEREN'T RUNNING TESTS ON, DID YOU?

SUNIL DHAWAN: IF THEY'RE NOT RUNNING TESTS ON THEM, YEAH.

MR. WADE: RIGHT. SO TO THE EXTENT THAT YOU'RE BEING ASKED TO SIGN PAPERWORK THAT RELATES TO THE 3.5 DEVICE, THAT'S MAYBE -- WAS THAT JUST LIKE A MINISTERIAL FUNCTION TO MAKE SURE THAT EVERYTHING HAD BEEN DOCUMENTED AND THEY HAD IT FOR THE FILES?

SUNIL DHAWAN: THAT'S NORMALLY WHAT -- WHEN YOU'RE COSIGNING DOCUMENTS, THAT'S USUALLY TO MAKE SURE THAT, YEAH, THAT'S WHY IT'S DONE.

MR. WADE: AND THEN THEY LOG THEM IN THE FILES SO IF ANYONE HAS ANY QUESTIONS, THEY CAN COME AND PULL THEM OUT AND PEOPLE CAN LOOK AT THEM; CORRECT?

SUNIL DHAWAN: THAT'S USUALLY THE FUNCTION OF THAT, YES.

MR. WADE: OKAY. LET ME LOOK AT A COUPLE OF POLICIES. I PROMISE YOU I WON'T SHOW YOU EVERY DOCUMENT IN THE BINDER (INDICATING). MAY I APPROACH, YOUR HONOR?

BY MR. WADE:

MR. WADE: IF I COULD CALL YOUR ATTENTION TO EXHIBIT 9941, WHICH I BELIEVE SHOULD BE THE FIRST DOCUMENT IN THE BINDER. DO YOU SEE THAT?

MR. WADE: AND THIS IS A STANDARD OPERATING PROCEDURE FOR PROFICIENCY TESTING FOR THERANOS LAB DEVELOPED TESTS. DO YOU SEE THAT?

MR. WADE: AND YOU SIGNED OFF ON THIS IN SEPTEMBER OF 2015?

MR. WADE: MOVE THE ADMISSION OF 9941.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 9941 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: OKAY. AND THIS WAS, THIS WAS ONE OF THOSE DOCUMENTS WHERE, AFTER YOU CAME IN AND YOU WERE ENGAGED WITH THE COMPANY IN AUGUST AND SEPTEMBER, WHERE YOU WERE ASKED TO REVIEW AND SIGN; IS THAT CORRECT?

MR. WADE: AND YOU WERE RELYING UPON DR. SAKSENA AND DR. YOUNG AND THEIR EXPERTISE WHEN YOU SIGNED OFF ON THIS; IS THAT CORRECT?

MR. WADE: IN FACT, DO YOU RECALL THAT DR. SAKSENA WAS ACTUALLY IN THE PROCESS -- HE WAS A FULL-TIME EMPLOYEE AT THERANOS; CORRECT?

SUNIL DHAWAN: IF THAT'S IN THE RECORD, THEN YES.

MR. WADE: AND DO YOU RECALL ACTUALLY THAT HE WAS IN THE PROCESS OF GETTING SOME CERTIFICATIONS TO BECOME THE FULL-TIME LABORATORY DIRECTOR AT THERANOS AND SOUGHT YOUR ASSISTANCE IN CONNECTION WITH THAT?

SUNIL DHAWAN: I DON'T RECALL THAT.

MR. WADE: OKAY. WE'LL COME BACK TO THAT. BUT IN CONNECTION -- AND YOU SEE DR. YOUNG WAS A PH.D. AS WELL; CORRECT?

MR. WADE: OKAY. LET ME TURN YOU TOWARD THE BACK OF THE BINDER. LET ME TURN YOU TO EXHIBIT 9962. DO YOU HAVE THAT ONE IN FRONT OF YOU?

MR. WADE: AND DO YOU RECOGNIZE THIS TO BE THE QUALITY SYSTEMS MANUAL THAT YOU SIGNED OFF ON IN SEPTEMBER OF 2015?

MR. WADE: MOVE THE ADMISSION OF 9962.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 9962 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: AND AGAIN, THIS IS THE QUALITY SYSTEMS MANUAL THAT WAS PREPARED BY NUMEROUS PEOPLE WITHIN THE COMPANY AND YOU WERE ASKED TO REVIEW AND SIGN OFF ON; IS THAT RIGHT?

MR. WADE: AND THESE ARE PEOPLE WHO WERE ALL FULL-TIME EMPLOYEES AT THERANOS?

SUNIL DHAWAN: I BELIEVE SO, YES.

MR. WADE: AND DO YOU SEE DR. MASINDE IS THE ONE WHO ACTUALLY PREPARED THIS AS THE TECHNICAL SUPERVISOR?

MR. WADE: AND LANGLY GEE WAS INVOLVED IN THIS BECAUSE HE WAS DOING FULL-TIME QUALITY ASSURANCE AND QUALITY CONTROL WORK?

MR. WADE: OKAY. AND I WANT TO JUST DRAW YOUR ATTENTION TO THE LAST PAGE OF THIS WHICH SHOWS THE REVISION HISTORY. DO YOU SEE THAT?

MR. WADE: AND THE REVISION HISTORY YOU MADE -- BASED ON YOUR REVIEW OF THESE DOCUMENTS AND OTHER DOCUMENTS, DO YOU UNDERSTAND THAT ONE OF THE THINGS THAT THE FULL-TIME PEOPLE WOULD DO WITHIN THE COMPANY IS THAT THEY WOULD CONTINUOUSLY UPDATE AND IMPROVE THE PROCEDURES AS THEY GOT MORE AND MORE EXPERIENCE WITHIN THE LAB?

MR. WADE: AND THAT'S -- THIS REVISION HISTORY REFLECTS A NUMBER OF ITERATIONS OF THIS DOCUMENT?

MR. WADE: AND YOU WERE JUST BEING ASKED TO SIGN OFF ON THE LATEST COPY OF THIS WITH THE NEWEST IMPROVEMENTS; IS THAT RIGHT?

MR. WADE: OKAY. LET ME SHOW YOU ONE MORE. LET'S GO TO 110, WHICH I THINK IS THE SECOND TO THE LAST DOCUMENT IN THAT BINDER. SO THAT'S 10010 I GUESS I SHOULD SAY. DO YOU HAVE THAT IN FRONT OF YOU, DOCTOR?

MR. WADE: AND DO YOU RECOGNIZE THIS TO BE A QUALITY CONTROL STANDARD OPERATING PROCEDURE THAT YOU WERE ASKED TO SIGN OFF ON IN SEPTEMBER OF 2015?

MR. WADE: MOVE THE ADMISSION OF 10010.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED, AND IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10010 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: OKAY. SIMILAR TO OTHER DOCUMENTS, THERE ARE THREE FULL-TIME EMPLOYEES WHO HAD PREPARED THIS IN ADVANCE OF YOUR REVIEW OF IT; IS THAT CORRECT?

MR. WADE: INCLUDING MR. GEE, WHO WAS FULL TIME RESPONSIBLE FOR QUALITY CONTROL?

MR. WADE: AND OTHER PEOPLE WHO WERE -- HAD SENIOR FUNCTIONS WITHIN THE LAB AT THIS TIME; IS THAT RIGHT?

MR. WADE: OKAY. AND SIMILARLY, IF WE JUST GO TO THE BACK OF THE DOCUMENT AND LOOK AT THE REVISION HISTORY. AS WITH OTHER POLICIES AND PROCEDURES THAT YOU SAW IN THE LAB, THIS REFLECTED THAT THERE WERE NUMEROUS AND ONGOING ITERATIONS AND DEVELOPMENTS OF THE POLICIES WITHIN THE LAB; IS THAT RIGHT?

MR. WADE: OKAY. THANK YOU. YOU CAN SET THAT BINDER ASIDE. LET ME ASK YOU, IN THE WHITE BINDER YOU WERE ASKED ABOUT A POLICY BY MR. SCHENK, WHICH I BELIEVE IS EXHIBIT 3041, WHICH IS IN EVIDENCE. DO YOU SEE THAT?

MR. WADE: AND MR. SCHENK HAD ASKED YOU -- THIS RELATES TO CRITICAL VALUES; CORRECT?

MR. WADE: AND FROM YOUR TRAINING, YOU'RE VERY FAMILIAR WITH CRITICAL VALUES AND WHAT THEY ARE; RIGHT?

MR. WADE: OKAY. AND IF YOU GO -- AND I THINK THERE WAS SOME DISCUSSION ABOUT CRITICAL VALUES. I JUST WANT TO MAKE SURE THE RECORD IS CLEAR. THE CRITICAL VALUES ARE ALL ACTUALLY SET FORTH IN THE BACK OF THE DOCUMENT, IS THAT RIGHT, IN APPENDIX A ON PAGE 9?

MR. WADE: AND GOING FORWARD.

MR. WADE: AND JUST SO -- THERE MAY HAVE BEEN SOME CONFUSION. I JUST WANT TO MAKE SURE IT'S CLEAR. THIS GIVES THE GUIDELINES FOR WHAT ARE CONSIDERED TO BE CRITICAL VALUES BY THE COMPANY WHEN THEY GET RESULTS WITHIN THE LABORATORY; CORRECT?

MR. WADE: AND THEN IF YOU LOOK EARLY IN THE PROCEDURE, IT THEN SAYS EXACTLY WHAT PEOPLE ARE SUPPOSED TO DO WHEN THEY GET CRITICAL VALUES; RIGHT? IF I CAN CALL YOUR ATTENTION TO PAGE 4 OF THE EXHIBIT. DO YOU SEE UNDER PARAGRAPH 7 THERE'S ACTUALLY A VERY SPECIFIC PROCEDURE THERE?

MR. WADE: AND THAT PROCEDURE GOES DOWN TO THE LEVEL OF DETAIL WHERE THEY PROVIDE A SCRIPT AS TO EXACTLY WHAT IS SUPPOSED TO BE SAID WHEN A CRITICAL VALUE IS REPORTED TO A DOCTOR; RIGHT?

MR. WADE: AND THEY GIVE A SCRIPT AND A VERY PRECISE PROCEDURE ABOUT WHAT IS SUPPOSED TO HAPPEN WHEN A CRITICAL VALUE IS REPORTED TO A PATIENT; CORRECT? IF YOU LOOK ON THE NEXT PAGE?

MR. WADE: AND DID THIS SEEM LIKE A GOOD PROCEDURE TO YOU?

MR. WADE: OKAY. AND IF YOU GO TO THE FRONT PAGE OF THAT AGAIN JUST QUICKLY. BY THE TIME THIS WAS PREPARED, DO YOU SEE THAT THERE WAS A NEW LABORATORY MANAGER REFLECTED THERE?

MR. WADE: MS. CENDEJAS. AND THEN THERE'S A NEW TECHNICAL SUPERVISOR AND A NEW GENERAL SUPERVISOR. DO YOU SEE THAT?

MR. WADE: AND DO YOU RECALL THAT TOWARD THE END OF 2015 THAT THERE WERE ACTUALLY A NUMBER OF NEW AND ADDITIONAL EXPERTS WHO WERE BROUGHT IN TO THE LAB, NEW NAMES THAT WERE APPEARING?

SUNIL DHAWAN: YEAH, THE NAMES THAT I SEE HERE, YES.

MR. WADE: OKAY. LET'S GO TO 10527.

MR. WADE: DO YOU HAVE THAT IN FRONT OF YOU, DOCTOR?

MR. WADE: AND I BELIEVE THIS -- WE TALKED ABOUT DIFFERENT EMAILS OF THIS NATURE PREVIOUSLY. DO YOU RECALL THAT?

MR. WADE: AND MR. SCHENK I BELIEVE SHOWED YOU THE BOTTOM EMAIL IN THIS CHAIN. DO YOU RECALL THAT?

MR. WADE: I MOVE THE ADMISSION OF 10527.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(DEFENDANT'S EXHIBIT 10527 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: THIS WAS THE EMAIL WHERE YOU WERE ASKING THAT DOCTOR -- OR MR. GEE SEND YOU ONLY 50 POLICIES A WEEK; CORRECT?

MR. WADE: AND I'M ASKING YOU THIS BECAUSE I WANT TO ASK SOME QUESTIONS ABOUT THAT PERIOD LEADING UP TO THE CMS AUDIT AND SOME QUESTIONS RELATING TO THAT.

MR. WADE: AND SO THAT KIND OF RAMP UP PERIOD STARTS HERE IN -- BLESS YOU -- IN EARLY AUGUST?

MR. WADE: AND LET'S LOOK AT 10528, WHICH I BELIEVE IS IN EVIDENCE. IT MIGHT BE A DIFFERENT -- THE COURT'S INDULGENCE FOR A MOMENT.

(PAUSE IN PROCEEDINGS.)

MR. WADE: YOUR HONOR, THIS DOCUMENT MAY BE IN EVIDENCE, AND WE'LL WORK IT OUT LATER. IT'S THE SAME DOCUMENT. I'LL JUST MOVE IT IN AND WE CAN CLARIFY THAT.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED.

(DEFENDANT'S EXHIBIT 10528 WAS RECEIVED IN EVIDENCE.)

MR. WADE: I JUST WANT TO MAKE SURE THAT THE REDACTIONS ARE APPROPRIATE, AND I'M COMFORTABLE WITH THIS DOCUMENT.

MR. WADE: DO YOU HAVE 10528 IN FRONT OF YOU, SIR?

MR. WADE: OKAY. I THINK YOU WERE ASKED SOME QUESTIONS ABOUT THIS BY MR. SCHENK. DO YOU RECALL THAT?

MR. WADE: AND AGAIN, THIS IS THE PERIOD WHERE DR. SAWYER LEFT AND YOU WERE BEING ASKED TO SPEND MORE TIME AT THE COMPANY?

MR. WADE: OKAY. AND MR. BALWANI HAD TALKED TO YOU ABOUT -- YOU SEE HERE IN THE THIRD FULL PARAGRAPH, HE SAYS THAT WE HAVE A LAB AUDIT COMING UP ON 9/22 AT 9:00 A.M. DO YOU SEE THAT?

MR. WADE: AND HE NOTED THAT THEY HAPPEN EVERY TWO YEARS; RIGHT?

MR. WADE: AND YOU KNEW THAT BECAUSE YOU HAD BEEN THROUGH THESE BEFORE; CORRECT?

MR. WADE: AND HE WANTED TO SEE IF YOU COULD BE PRESENT FOR THAT; IS THAT RIGHT?

MR. WADE: OKAY. AND HE THEN STATES, "I HAVE A VERY CAPABLE TEAM THAT HAS TAKEN CARE OF ALL OF THE DETAILS AS ALWAYS, BUT WOULD LIKE TO HAVE YOU HERE FOR THE FIRST PART OR SO AND THE INTRODUCTION OF OUR TEAM." DO YOU SEE THAT?

MR. WADE: OKAY. AND DO YOU REMEMBER DISCUSSING WITH MR. BALWANI THAT THE COMPANY HAD BROUGHT IN SOME OUTSIDE EXPERTS TO HELP IT PREPARE AND DO MOCK AUDITS IN ADVANCE OF THIS CMS AUDIT?

SUNIL DHAWAN: I DON'T RECALL THOSE CONVERSATIONS. THIS IS GOING BACK SIX YEARS. SO IF THEY HAPPENED, THEY HAPPENED. BUT I DON'T RECALL THE SPECIFIC CONVERSATIONS ABOUT THE MOCK AUDITS.

MR. WADE: OKAY. FAIR ENOUGH. I'LL SHOW YOU SOME DOCUMENTS AND SEE IF I CAN REFRESH YOUR RECOLLECTION IN A MINUTE.

MR. WADE: BUT DO YOU SEE THAT HE SAID THAT HE HAD A FULL TEAM WHO WAS PREPARING FOR IT; RIGHT?

MR. WADE: OKAY. AND HE NOTES HERE THAT HE WILL PERSONALLY WALK YOU THROUGH THE LATEST UPDATES WITH THE TEAM; RIGHT?

MR. WADE: AND I THINK YOU TESTIFIED ABOUT THAT. YOU WENT AND YOU DID A WALK THROUGH WITH THE WHOLE TEAM; CORRECT?

MR. WADE: AND WAS THAT HELPFUL TO YOU?

MR. WADE: AND THE NEXT CLAUSE THERE SAYS, "WE HAVE HIRED MANY EXPERTS FROM THE INDUSTRY TO MAKE SURE LAB IS FLAWLESS AND AUDIT READY, SO I DON'T ANTICIPATE ANY HICKUPS, BUT AS ALWAYS, WANTED YOU TO BE FAMILIAR WITH IT." DO YOU SEE THAT?

MR. WADE: OKAY. SO WAS IT YOUR UNDERSTANDING THAT MR. BALWANI, GOING INTO THIS AUDIT, THOUGHT THAT THE LAB WAS IN GREAT SHAPE; RIGHT?

MR. SCHENK: OBJECTION. SPECULATION.

JUDGE DAVILA: YOU'RE ASKING HIM WHAT MR. BALWANI THOUGHT.

MR. WADE: I'M ASKING IF IT WAS HIS UNDERSTANDING BASED ON WHAT MR. BALWANI TOLD HIM IN THIS DOCUMENT.

JUDGE DAVILA: WELL, YOU CAN ASK HIM ABOUT WHAT THE DOCUMENT SAYS.

MR. WADE: WELL, I -- I BELIEVE I CAN ASK HIM ABOUT HIS UNDERSTANDING ABOUT -- BASED ON HIS INTERACTIONS WITH MR. BALWANI.

JUDGE DAVILA: YOU CAN ASK HIM WHAT DOES THIS DOCUMENT MEAN TO HIM.

MR. WADE: OKAY. WELL, YOUR HONOR, MAYBE IF I WITHDRAW THIS QUESTION AND TRY AGAIN, MAYBE I'LL DRAW ANOTHER OBJECTION.

MR. WADE: WAS IT YOUR UNDERSTANDING, BASED ON THE COMMUNICATIONS WITH MR. BALWANI, WRITTEN AND ORAL, THAT HE FELT LIKE THE LAB WAS IN GOOD SHAPE GOING INTO THE AUDIT?

MR. SCHENK: SPECULATION.

JUDGE DAVILA: SUSTAINED. YOU CAN ASK IT ANOTHER WAY.

BY MR. WADE:

MR. WADE: WAS IT YOUR UNDERSTANDING AS A RESULT OF THIS EMAIL, RECEIVING THIS EMAIL, THAT THE LAB -- THAT PEOPLE AT THERANOS BELIEVED THE LAB TO BE IN GOOD SHAPE?

MR. SCHENK: SPECULATION.

JUDGE DAVILA: WE CAN GO A LONG WAYS WITH THIS, BUT IS THERE ANOTHER WAY THAT YOU CAN ASK HIM THE QUESTION THAT IS NOT SPECULATION?

MR. WADE: I'M ASKING ABOUT HIS UNDERSTANDING AND HE'S COMMUNICATING ON THESE ISSUES.

JUDGE DAVILA: AND THE OBJECTION HAS BEEN SPECULATION AND THE COURT SUSTAINED IT, SO --

BY MR. WADE:

MR. WADE: YOU RECEIVED THIS COMMUNICATION FROM MR. BALWANI; CORRECT?

SUNIL DHAWAN: THE EMAIL, YES.

MR. WADE: OKAY. AND YOU SEE WHERE HE SAYS, "WE HAVE HIRED MANY EXPERTS," RIGHT? YOU SEE THAT?

MR. WADE: AND HE SAYS THAT THEY WANT TO MAKE SURE THAT THE LAB IS FLAWLESS AND AUDIT READY. DO YOU SEE THAT?

MR. WADE: AND YOU SEE WHERE HE SAYS HE DOESN'T ANTICIPATE ANY HICCUPS. DO YOU SEE THAT?

MR. WADE: AND WHAT DID YOU UNDERSTAND HIM TO MEAN BY HE DIDN'T ANTICIPATE ANY HICCUPS?

SUNIL DHAWAN: THAT THERE SHOULDN'T BE ANY ISSUES.

MR. WADE: IN THE INSPECTION?

MR. WADE: OKAY. BUT NOTWITHSTANDING ALL OF THOSE OUTSIDE EXPERTS WHO WERE INVOLVED, HE WANTED TO MAKE SURE THAT YOU COULD COME AND BE COMFORTABLE WITH EVERYTHING; CORRECT?

SUNIL DHAWAN: HE WANTED ME TO BE THERE FOR AT LEAST PART OF THAT INSPECTION, YES.

MR. WADE: AND FOR A WALK THROUGH IN ADVANCE OF THAT; CORRECT?

MR. WADE: AND YOU ACTUALLY IN THIS PERIOD, STARTING AUGUST 8TH, OR WHATEVER IT IS, UNTIL SEPTEMBER, YOU MADE A COUPLE OF TRIPS TO THE COMPANY; CORRECT?

SUNIL DHAWAN: I DON'T RECALL THE NUMBER, BUT I DID MAKE TRIPS TO THE COMPANY, YES.

MR. WADE: OKAY. AND WHEN YOU WERE AT THE COMPANY, DID YOU INTERACT WITH OTHER -- YOU INTERACTED WITH SOME OF THE OTHER LAB EMPLOYEES AS WELL?

SUNIL DHAWAN: I MET THEM.

MR. WADE: AND THEY SHOWED YOU THE DIFFERENT -- THE STATE OF THE LAB AT THE TIME?

SUNIL DHAWAN: YES, WE DID A WALK THROUGH.

MR. WADE: OKAY. AND DID THEY COMMUNICATE TO YOU THE READINESS FOR THE CLIA INSPECTION?

SUNIL DHAWAN: WE DIDN'T HAVE ANY CONVERSATIONS -- I DIDN'T HAVE ANY CONVERSATIONS PARTICULARLY ABOUT THE READINESS FOR THE CLIA INSPECTION.

MR. WADE: OKAY. JUST THESE COMMUNICATIONS WITH MR. BALWANI?

SUNIL DHAWAN: PREDOMINANTLY WITH MR. BALWANI, YES.

MR. WADE: OKAY. AND THEN DO YOU RECALL THAT THE COMPANY HAD A LABORATORY CONSULTING FIRM THAT IT USED TO HELP MAKE SURE ITS POLICIES AND PROCEDURES WERE STATE OF THE ART AND THAT IT WAS PREPARED FOR THE CLIA INSPECTIONS?

SUNIL DHAWAN: HE INDICATED THAT THERE WAS A COMPANY INVOLVED WITH THAT, YES.

MR. WADE: OKAY. AND DO YOU RECALL THE NAME JERRY HURST? IS THAT A NAME THAT IS FAMILIAR TO YOU?

SUNIL DHAWAN: I DON'T RECALL THAT NAME.

MR. WADE: OKAY. LET ME JUST SEE IF I COULD REFRESH YOUR RECOLLECTION. TAKE A LOOK AT 13173. JUST READ IT TO YOURSELF AND LET ME KNOW WHEN YOU'VE HAD A CHANCE TO REVIEW THE EMAIL, SIR.

(PAUSE IN PROCEEDINGS.)

SUNIL DHAWAN: I'M DONE.

BY MR. WADE:

MR. WADE: DOES THIS REFRESH YOUR RECOLLECTION THAT THERE WAS A GENTLEMEN NAMED JERRY HURST AT LABORATORY CONSULTING SERVICES WHO HELPED THE COMPANY PREPARE WITH MOCK AUDITS FOR THE CLIA INSPECTION?

SUNIL DHAWAN: I WAS MADE AWARE THAT SOMEBODY WAS HELPING WITH A MOCK AUDIT, BUT I DIDN'T KNOW IT WAS MR. HURST.

MR. WADE: OKAY. AND DO YOU KNOW WHETHER THE COMPANY ACTUALLY DID MULTIPLE MOCK AUDITS?

SUNIL DHAWAN: I WAS NEVER TOLD THAT.

MR. WADE: OKAY. LET'S TAKE A LOOK AT 4528.

COURT CLERK: 452A OR 8?

MR. WADE: AND I THINK ON YOUR DIRECT TESTIMONY YOU SAID WHEN YOU ATTENDED THE AUDIT THAT THERE WAS SORT OF AN INTRODUCTORY PRESENTATION THAT WAS GIVEN TO THE PEOPLE WHO WERE COMING IN FOR THE INSPECTION. DO YOU RECALL THAT?

SUNIL DHAWAN: EVERYONE WAS INTRODUCED.

MR. WADE: YEAH. AND DO YOU RECALL THE POWERPOINT PRESENTATION THAT WAS GIVEN ON SEPTEMBER 22ND, 2015 TO THOSE INSPECTORS?

SUNIL DHAWAN: I DON'T RECALL THE EXACT PRESENTATION.

MR. WADE: OKAY. WELL, HAVE A LOOK AT EXHIBIT 4528 AND SEE IF THIS -- IF YOU RECOGNIZE THIS TO BE A POWERPOINT PRESENTATION THAT WAS GIVEN TO THE CLIA INSPECTORS?

(PAUSE IN PROCEEDINGS.)

SUNIL DHAWAN: THIS LOOKS LIKE A CLIA PRESENTATION, YEAH.

BY MR. WADE:

MR. WADE: AND DO YOU RECALL BEING THERE FOR THAT PRESENTATION, AT LEAST THE INTRODUCTION PORTION OF THAT PRESENTATION?

SUNIL DHAWAN: THE INTRODUCTION, YES.

MR. WADE: MOVE THE ADMISSION OF 4528.

MR. SCHENK: FOUNDATION.

JUDGE DAVILA: MAYBE A LITTLE MORE FOUNDATION WOULD BE HELPFUL.

BY MR. WADE:

MR. WADE: I BELIEVE YOU TESTIFIED THAT EVERYONE SORT OF GATHERED INITIALLY AND THERE WERE A NUMBER OF PEOPLE WHO WERE AROUND THE TABLE AND YOU WERE SORT OF SITTING IN THE BACK; IS THAT RIGHT?

MR. WADE: AND AS PART OF THAT -- THIS WAS ON SEPTEMBER 22ND, 2015?

MR. WADE: AND THEN AS PART OF THE INTRODUCTION, THE COMPANY WANTED TO GIVE SOME OVERVIEW INFORMATION ABOUT THEIR LAB OPERATIONS. DO YOU RECALL THAT?

MR. WADE: AND KIND OF INTRODUCE WHO THE RELEVANT PEOPLE WERE IN THE CLIA LAB?

MR. WADE: AND THEY DISPLAYED A POWERPOINT PRESENTATION AND KIND OF WALKED THEM THROUGH THAT. DO YOU RECALL THAT?

SUNIL DHAWAN: NOW THAT YOU'VE REFRESHED MY MEMORY, YES.

MR. WADE: AND THIS IS THAT PRESENTATION, CORRECT, SIR?

SUNIL DHAWAN: IT LOOKS LIKE IT.

MR. WADE: OKAY. I MOVE THE ADMISSION OF 4528.

MR. SCHENK: NO OBJECTION.

JUDGE DAVILA: IT'S ADMITTED. IT MAY BE PUBLISHED.

(GOVERNMENT'S EXHIBIT 4528 WAS RECEIVED IN EVIDENCE.)

BY MR. WADE:

MR. WADE: OKAY. LET'S GO AND LOOK AT A COUPLE OF THESE SLIDES. IN PARTICULAR, LET'S GO TO I BELIEVE IT'S SLIDE 7. THIS IS THE ORG CHART FOR THE CLIA LAB THAT WAS DISPLAYED FOR THE INSPECTORS; IS THAT RIGHT?

SUNIL DHAWAN: IT LOOKS LIKE IT, YES.

MR. WADE: YES. AND THIS SHOWS ALL OF THE DIFFERENT PERSONNEL WHO WERE INVOLVED IN THE OPERATION OF THE CLIA LAB; IS THAT RIGHT?

SUNIL DHAWAN: YES, YES.

MR. WADE: OKAY. INCLUDING THE PEOPLE -- AT THIS TIME THERE WERE TWO PEOPLE SERVING AS THE GENERAL SUPERVISOR; IS THAT RIGHT?

MR. WADE: AND THERE WAS ONE PERSON SERVING AS THE TECHNICAL SUPERVISOR; RIGHT?

MR. WADE: AND THOSE BELOW THE LABORATORY DIRECTOR, THOSE ARE THE HIGHEST POSITIONS WITHIN A CLIA LAB; IS THAT RIGHT?

SUNIL DHAWAN: USUALLY, YES.

MR. WADE: OKAY. AND THEN IF WE JUST GO TO THE NEXT PAGE -- WE WILL NEED TO WIPE THIS, MS. KRATZMANN. THANK YOU. THE NEXT PAGE, DO YOU SEE THE SPECIFIC PERSONNEL WHO ARE INVOLVED IN ALL OF THESE OPERATIONS ARE IDENTIFIED?

MR. WADE: AND THIS WAS A BIG OPERATION; IS THAT RIGHT?

SUNIL DHAWAN: A LARGE NUMBER OF PEOPLE, YES.

MR. WADE: YEAH. AND IF YOU GO TO PAGE 11. YOUR CREDENTIALS ARE IDENTIFIED THERE. DO YOU SEE THAT?

MR. WADE: AND IF YOU GO -- AND WE'VE TALKED ABOUT THOSE IN YOUR DIRECT AND IN OUR INTRODUCTORY INTERACTIONS. IF YOU GO TO THE NEXT PAGE, YOU SEE DR. DANIEL YOUNG --

MR. WADE: -- IS IDENTIFIED THERE. AND DO YOU RECALL AT THIS TIME, IN ADDITION TO THE HIGH COMPLEXITY LABORATORY THAT YOU SERVED AS THE LAB DIRECTOR FOR, THERE WAS A MODERATE COMPLEXITY LABORATORY IN ARIZONA?

SUNIL DHAWAN: YES, AND MY UNDERSTANDING WAS THAT DR. YOUNG WAS THE LAB DIRECTOR THERE.

MR. WADE: HE SERVED AS THE LAB DIRECTOR THERE; CORRECT?

MR. WADE: AND THAT'S REFLECTED HERE. DO YOU SEE THAT?

MR. WADE: AND HE WAS ALSO INVOLVED IN ASSISTING WITH THE OPERATIONS OF THE NEWARK LAB AS WELL; CORRECT?

SUNIL DHAWAN: THAT WAS MY UNDERSTANDING.

MR. WADE: YEAH. AND IF YOU GO TO PAGE 14. WE HAD TALKED ABOUT DR. SAKSENA. DO YOU RECALL THAT?

MR. WADE: AND DR. SAKSENA HAD HAD SIGNIFICANT EXPERIENCE WORKING AS THE DIRECTOR OF ASSAY SYSTEMS AT THERANOS. DO YOU RECALL THAT?

SUNIL DHAWAN: THAT'S WHAT IT STATES HERE, YES.

MR. WADE: AND THEN IN ADDITION TO THAT THIS GOES THROUGH -- IF WE GO TO 15 BRIEFLY -- THIS SETS FORTH THE QUALIFICATIONS AND EXPERIENCE OF DR. MASINDE. DO YOU SEE THAT?

MR. WADE: AND THE NEXT PAGE, THE QUALIFICATIONS OF MS. ALAMDAR. DO YOU SEE THAT?

MR. WADE: AND THEN THE NEXT PAGE, MR. SIDHU TOOK ON A -- HAD A SENIOR ROLE IN THE LAB. DO YOU RECALL THAT?

MR. WADE: AND THEN FINALLY THE NEXT -- IT'S MR. GEE WAS THE LONG-TIME QUALITY CONTROL MANAGER; CORRECT?

MR. WADE: AND DO YOU RECALL THAT IN CONNECTION WITH THESE INTERACTIONS WITH THE REGULATORS IN 2015, THAT ONE OF THE REGULATORS CAME IN AND MADE COMMENTS ABOUT HOW CMS WAS UNDER PRESSURE TO INSPECT THERANOS BECAUSE OF REPORTERS THAT WERE MAKING INQUIRIES OF CMS. DO YOU RECALL THAT?

SUNIL DHAWAN: I OVERHEARD THAT, YES.

MR. WADE: YEAH. AND THAT THEY WERE SAYING THAT AS A RESULT OF THOSE INQUIRIES, THEY FELT A NEED TO COME IN IN A PARTICULAR WAY IN THAT INSPECTION?

SUNIL DHAWAN: I DIDN'T HEAR THAT STATEMENT.

MR. WADE: OKAY. WELL, WHAT DO YOU RECALL BEING SAID BY THAT REGULATOR?

SUNIL DHAWAN: THAT IT WAS REPEATEDLY SAID THAT THEY WERE UNDER SCRUTINY.

MR. WADE: UH-HUH.

SUNIL DHAWAN: THAT WAS BASICALLY MY UNDERSTANDING.

MR. WADE: DO YOU RECALL WHETHER ANY OF THE REGULATORS SUGGESTED THAT THERE WAS A PARTICULAR REPORTER WHO WAS ON A CRUSADE AGAINST THE COMPANY?

SUNIL DHAWAN: I DON'T RECALL THAT.

MR. WADE: LET ME SEE IF I CAN REFRESH YOUR -- TAKE A LOOK AT 15324. YOU'RE NOT ON THIS DOCUMENT. JUST READ IT TO YOURSELF FOR A SECOND, DOCTOR.

(PAUSE IN PROCEEDINGS.)

BY MR. WADE:

MR. WADE: DOES THAT REFRESH YOUR RECOLLECTION THAT SOMEONE WITHIN CMS THOUGHT A PARTICULAR REPORTER WAS ON A CRUSADE AGAINST THE COMPANY?

SUNIL DHAWAN: I DIDN'T HEAR THAT SPECIFIC STATEMENT.

MR. WADE: OKAY. DID YOU COME LATER -- I THINK MR. SCHENK ASKED YOU SOME QUESTIONS, YOU WERE CONTACTED BY REPORTERS YOURSELF. DO YOU RECALL THAT?

MR. WADE: AND WERE YOU AWARE THAT THERE WAS A REPORTER WHO WAS ACTUALLY THREATENING TO WRITE A STORY SUGGESTING THAT YOU WERE NOT LEGALLY QUALIFIED TO SERVE AS THE LABORATORY DIRECTOR?

SUNIL DHAWAN: I DON'T RECALL -- I DON'T REMEMBER GETTING -- HEARING ABOUT THAT.

MR. WADE: OKAY. BUT YOU WERE LEGALLY QUALIFIED TO SERVE AS A LAB DIRECTOR; CORRECT?

SUNIL DHAWAN: I HAVE THE DEGREES AND THE -- YES.

MR. WADE: AND YOU MET THE REQUIREMENTS, CORRECT, SIR?

SUNIL DHAWAN: THE STATUTORY REQUIREMENTS.

MR. WADE: OKAY. I HAVE NO FURTHER QUESTIONS AT THIS TIME, YOUR HONOR. I PASS THE WITNESS. THANK YOU, DOCTOR.

JUDGE DAVILA: REDIRECT?

MR. SCHENK: YES, YOUR HONOR.

REDIRECT EXAMINATION BY MR. SCHENK:

MR. SCHENK: GOOD MORNING, DR. DHAWAN.

SUNIL DHAWAN: GOOD MORNING, SIR.

MR. SCHENK: I JUST WANT TO FOLLOW UP ON A COUPLE OF QUESTIONS THAT MR. WADE ASKED YOU, AND I'LL TELL YOU SORT OF THE THEME OF MY QUESTIONS IS GOING TO BE TO JUST CLARIFY, WHEN YOU WERE ANSWERING QUESTIONS, WHETHER YOU WERE MAKING ASSUMPTIONS IN YOUR ANSWERS OR WHETHER YOU KNEW THE FACTS THAT YOU WERE SHARING. AND I WANT TO START WITH -- I DON'T HAVE A PARTICULAR PLACE TO POINT YOU TO, IT WAS ASKED OF YOU REPEATEDLY -- WHETHER THIS EMPLOYEE WAS A FULL-TIME EMPLOYEE AT THERANOS, FILL IN THE BLANK WITH AN EMPLOYEE'S NAME, AND YOU WERE ASKED IF THAT EMPLOYEE WAS A FULL-TIME EMPLOYEE. YOU ANSWERED AT SOME TIMES YES. DID YOU KNOW THAT THAT WAS A FULL TIME EMPLOYEE OR WERE YOU MAKING ASSUMPTIONS?

SUNIL DHAWAN: IT WAS ASSUMPTIONS.

SUNIL DHAWAN: BASED ON SEEING THEM IN THE LAB, MY ASSUMPTION WAS THAT THEY WERE FULL-TIME EMPLOYEES.

MR. SCHENK: WHEN YOU WERE TELLING THIS JURY THAT X EMPLOYEE WAS A FULL-TIME EMPLOYEE, YOU WERE SAYING, SORT OF BASED ON WHAT I WOULD ASSUME TO BE TRUE. BUT YOU NEVER MET THAT PARTICULAR EMPLOYEE, SO YOU DIDN'T KNOW WHETHER THEY WERE FULL TIME; IS THAT FAIR?

SUNIL DHAWAN: I DIDN'T SEE THEIR EMPLOYMENT RECORD, SO I COULDN'T SAY THEY WERE FULL TIME. I WOULD SEE THEM AT THE LAB, BUT THAT'S ABOUT IT.

MR. SCHENK: OKAY. AND DID YOU EVER HAVE A CONVERSATION WITH AN EMPLOYEE WITHIN THE LAB WHERE YOU ASKED THAT PERSON WHETHER THEY WERE FULL TIME OR NOT?

SUNIL DHAWAN: I NEVER ASKED THAT QUESTION.

MR. SCHENK: YOU WERE ASKED A GROUP OF QUESTIONS ABOUT LYNETTE SAWYER. DO YOU REMEMBER THAT?

MR. SCHENK: AND DO YOU KNOW WHETHER LYNETTE SAWYER EVER VISITED THE LAB?

SUNIL DHAWAN: I NEVER MET -- I DON'T RECALL EVER MEETING LYNETTE SAWYER, SO I CAN'T TELL YOU WHETHER SHE EVER WENT TO THE LAB.

MR. SCHENK: DO YOU KNOW WHETHER LYNETTE SAWYER WAS EVER SHOWN THE EDISON DEVICE?

SUNIL DHAWAN: I DON'T KNOW ANY OF THAT.

MR. SCHENK: DO YOU KNOW WHETHER THERANOS GAVE LYNETTE SAWYER SOP'S INVOLVING FDA CLEARED DEVICES AND THEN GAVE YOU THE EDISON SOP'S? DO YOU KNOW WHETHER THAT HAPPENED OR NOT?

SUNIL DHAWAN: I DO NOT.

MR. SCHENK: MR. WADE ASKED YOU, WHEN YOU WERE SIGNING SOP'S OR VALIDATION DOCUMENTS, IF YOU WERE RELYING ON THE GOOD WORK OF OTHER EMPLOYEES, THE NAMES THAT APPEARED ON THOSE DOCUMENTS BEFORE YOUR NAME. DO YOU RECALL THOSE QUESTIONS?

MR. SCHENK: AND YOU SAID YES, THAT YOU WERE RELYING ON THEIR GOOD WORK. I'M WONDERING IF YOU WERE MAKING AN ASSUMPTION THAT THEY HAD DONE GOOD WORK, OR DO YOU KNOW THAT THEY HAD DONE GOOD WORK?

SUNIL DHAWAN: I WAS ASSUMING THAT THEY HAD DONE GOOD WORK.

MR. SCHENK: OKAY. AND WHEN YOU SAW THAT THE DOCUMENT WAS MULTIPLE PAGES, THE VALIDATION REPORT OR THE SOP --

MR. SCHENK: -- AND IF THAT DOCUMENT HAD ADDITIONAL INFORMATION, LIKE DATA, WERE YOU MAKING THE ASSUMPTION THAT THAT DATA WAS ACCURATE?

SUNIL DHAWAN: YES. I WOULD ASSUME IF IT WAS THERE, IT WOULD BE ACCURATE.

MR. SCHENK: YOU DIDN'T ASK ANYBODY FOR INFORMATION TO SUBSTANTIATE THE DATA; IS THAT RIGHT?

SUNIL DHAWAN: MY ASSUMPTION WAS THAT THE DATA WAS CORRECT, SO I DIDN'T GO FURTHER.

MR. SCHENK: OKAY. AND WHEN YOU WERE REVIEWING THOSE DOCUMENTS AND ASSUMING THAT THE INDIVIDUALS WHO SIGNED IT BEFORE YOU, WERE YOU ASSUMING THAT THEY HAD LOOKED AT THE UNDERLYING DATA?

SUNIL DHAWAN: THAT'S GENERALLY THE STANDARD, THAT THEY HAVE LOOKED AT THE DATA, AND THAT'S USUALLY WHAT HAPPENS.

MR. SCHENK: OKAY. MR. WADE ASKED YOU HOW MANY EMPLOYEES WERE IN YOUR LAB AT THE DERMATOLOGY PRACTICE. DO YOU RECALL THAT?

SUNIL DHAWAN: UH-HUH, YES.

MR. SCHENK: AND I THINK YOU SAID THERE WERE TWO OR THREE.

MR. SCHENK: IS THAT RIGHT? HOW MANY WORKED AT THERANOS, DO YOU KNOW?

SUNIL DHAWAN: THE NUMBER HERE, WHICH IS, YOU KNOW, 20, 30, 40, EXCLUDING THE PEOPLE ON THE PHONE, THE BANK AND ALL THE OTHER PLACES. I MEAN, YEAH, IT WAS A LARGE NUMBER OF PEOPLE.

MR. SCHENK: SIGNIFICANTLY MORE PEOPLE WORKED AT THERANOS THAN IN YOUR LAB?

MR. SCHENK: AND AS LAB DIRECTOR, DID YOU SPEND SIGNIFICANTLY MORE TIME WORKING AT YOUR LAB THAN AT THERANOS?

MR. SCHENK: AND WERE THE TESTS THAT WERE BEING DONE AT THERANOS MORE COMPLICATED OR MORE DIFFICULT THAN THE TESTS THAT YOU RAN IN YOUR LAB?

MR. SCHENK: WHY DO YOU SAY THAT?

SUNIL DHAWAN: BECAUSE THERE WERE MORE COMPLEX BLOOD TESTS BEING DONE THERE.

MR. SCHENK: AND WERE YOU ASSUMING THAT PEOPLE AT THERANOS WERE CONDUCTING THOSE TESTS IN AN ACCURATE MANNER?

SUNIL DHAWAN: THAT WAS MY ASSUMPTION.

MR. SCHENK: AND DID DO YOU ANYTHING TO CONFIRM THAT?

SUNIL DHAWAN: I DIDN'T HAVE ANY REASON OR NEED TO CONFIRM IT.

MR. SCHENK: AND WHY DO YOU SAY THAT?

SUNIL DHAWAN: MY ASSUMPTION IS THAT PEOPLE WITH ADVANCED DEGREES SUCH AS MINE ARE GOING TO DO WORK ACCURATELY AND APPROPRIATELY.

MR. SCHENK: OKAY. SO EVEN WHEN YOU WERE WORKING AT THERANOS, YOU WERE MAKING SOME ASSUMPTIONS?

SUNIL DHAWAN: YES, YES.

MR. SCHENK: YOU WERE ASSUMING -- GOT IT. GOT IT. IN YOUR CURRENT LAB, HOW OFTEN DO YOU SPEAK TO THOSE TWO OR THREE EMPLOYEES?

SUNIL DHAWAN: SIX, EIGHT TIMES A DAY.

MR. SCHENK: WAS THERE -- OTHER THAN MR. BALWANI --

MR. SCHENK: -- WAS THERE ANY EMPLOYEE AT THERANOS THAT YOU EVER SPOKE TO SIX OR EIGHT TIMES THE ENTIRE TIME YOU WORKED AT THERANOS?

SUNIL DHAWAN: NOT THAT I CAN RECALL, NO.

MR. SCHENK: BUT YOUR OWN EMPLOYEES YOU SPEAK TO SIX OR EIGHT TIMES EACH DAY?

SUNIL DHAWAN: WE HAVE TO.

MR. SCHENK: WITH LESS COMPLICATED TESTS?

MR. SCHENK: MR. WADE SHOWED YOU VALIDATION REPORTS THAT MS. SAWYER SIGNED?

MR. SCHENK: DO YOU RECALL THAT? ONE WAS FOR A SIEMENS DEVICE?

MR. SCHENK: AND ONE WAS FOR A ROCHE DEVICE?

MR. SCHENK: AND DID YOU EVER SEE THERANOS RUNNING SIEMENS MACHINES? DID YOU INVESTIGATE THE WAY THAT THERANOS WAS USING THE SIEMENS MACHINES?

SUNIL DHAWAN: I WOULD -- I NEVER HAD THE OPPORTUNITY TO.

MR. SCHENK: AND HOW ABOUT THE ROCHE?

SUNIL DHAWAN: NEVER HAD THE OPPORTUNITY TO.

MR. SCHENK: ON ONE OF THE ROSTERS, OR MAYBE MORE THAN ONE, I SAW MR. BALWANI'S NAME.

MR. SCHENK: DID YOU KNOW THAT MR. BALWANI WAS WORKING IN THE LAB?

SUNIL DHAWAN: I SAW HIS NAME ON THE ROSTER. MY ASSUMPTION WAS THAT HE WAS WORKING IN THE LAB.

MR. SCHENK: IN ANY OF YOUR CONVERSATIONS WITH HIM BEFORE YOU TOOK THE JOB, OR AT THE TIME, DID HE TELL YOU THAT HE WAS WORKING IN THE LAB?

SUNIL DHAWAN: OTHER THAN CHIEF OPERATING OFFICER, NO. I MEAN, THERE WAS NO STATEMENT THERE.

MR. SCHENK: AND I THINK HE WAS LISTED UNDER A CLA, A CLINICAL LABORATORY ASSISTANT; IS THAT RIGHT?

SUNIL DHAWAN: I'D HAVE TO LOOK AT THE DOCUMENT, BUT, YES, I BELIEVE SO.

MR. SCHENK: OKAY. AND IS IT -- AND I'M HAPPY TO SHOW YOU THAT DOCUMENT. MAYBE LET'S DO THAT. THE BINDER IN FRONT OF YOU, THE EXHIBIT THAT THE DEFENSE WAS SHOWING YOU IN A BLACK BINDER, 4528. THAT WAS THE POWERPOINT FOR THE CMS INSPECTION.

SUNIL DHAWAN: WHICH SLIDE WOULD YOU LIKE ME TO GO TO?

MR. SCHENK: MY -- THE COPY I HAVE DOESN'T HAVE PAGE NUMBERS. IT'S, I WOULD SAY, ABOUT SEVEN OR EIGHT PAGES IN. IT'S AN ORG CHART?

SUNIL DHAWAN: YEAH, THE COMPLICATED ORG CHART.

MR. SCHENK: AND SO IF YOU LOOK ALL OF THE WAY TO THE RIGHT UNDER CLINICAL LABORATORY ASSISTANT, DO YOU SEE MR. BALWANI LISTED THERE?

MR. SCHENK: MS. KRATZMANN, COULD I -- THANK YOU.

MR. SCHENK: SO YOU SEE THE CLINICAL LABORATORY ASSISTANT BUBBLE, AND WITHIN THAT YOU SEE MR. BALWANI'S NAME?

MR. SCHENK: AND IN YOUR EXPERIENCE, DO CLA'S MAKE ALL OF THE HIRING DECISIONS IN THE LAB?

SUNIL DHAWAN: NORMALLY IT'S SOMEBODY HIGHER UP THAN THAT.

MR. SCHENK: IN YOUR EXPERIENCE, DO CLA'S MAKE ALL OF THE FIRING DECISIONS IN THE LAB?

SUNIL DHAWAN: NO. NORMALLY IT'S HIGHER LEVEL PEOPLE IN THE LAB.

MR. SCHENK: AND IF A TEST THAT THE LAB IS RUNNING IS PRODUCING CONCERNING RESULTS, IT'S INACCURATE OR MAYBE FAILING QC, WHO MAKES THE DECISION TO STOP RUNNING THAT TEST?

SUNIL DHAWAN: THE HIGHER LEVEL EMPLOYEES, LABORATORY DIRECTORS, THE SUPERVISORS REPORTING UP TO THE LABORATORY DIRECTORS USUALLY.

MR. SCHENK: WAS THERE EVER AN OCCASION WHILE YOU WERE LABORATORY DIRECTOR AT THERANOS --

MR. SCHENK: -- WHERE YOU SAID, WE SHOULD STOP RUNNING THIS TEST?

SUNIL DHAWAN: I WAS NEVER GIVEN ANY DATA TO SAY THAT.

MR. SCHENK: MR. WADE SHOWED YOU SOME DOCUMENTS WHERE YOU WERE DELEGATING AUTHORITY. YOU DELEGATED AUTHORITY TO MS. ALAMDAR AND THEN MR. MASINDE. DO YOU RECALL THAT?

MR. SCHENK: AND WHEN YOU WERE TALKING ABOUT DELEGATING TO EITHER THE TECHNICAL SUPERVISOR OR THE GS, AGAIN, WERE YOU MAKING AN ASSUMPTION ASSUMING THAT THEY WERE DOING THEIR WORK, OR DID YOU KNOW THAT THEY WERE DOING THEIR WORK?

SUNIL DHAWAN: MY ASSUMPTION WAS THAT THEY WOULD BE DOING THEIR WORK.

MR. SCHENK: MR. WADE SHOWED YOU THE VALIDATION REPORT THAT I SHOWED YOU YESTERDAY ABOUT CRITICAL VALUES. DO YOU REMEMBER THAT?

MR. SCHENK: AND MR. WADE SHOWED YOU THAT THERE WAS A SCRIPT IN THERE THAT WAS TO BE READ. DO YOU RECALL THAT?

SUNIL DHAWAN: YES, YES.

MR. SCHENK: AND DO YOU KNOW WHETHER THERANOS WAS FOLLOWING THAT SOP IN PRACTICE?

SUNIL DHAWAN: I DO NOT KNOW THAT.

MR. SCHENK: DO YOU KNOW WHETHER THERANOS HAD A PRACTICE OF IGNORING A CRITICAL VALUE OR NOT?

SUNIL DHAWAN: I HAVE NO KNOWLEDGE OF THAT.

MR. SCHENK: SO WHEN YOU SEE AN SOP ABOUT CRITICAL VALUES AND THE SCRIPT, AND YOU SIGNED IT, WERE YOU MAKING THE ASSUMPTION THAT THERANOS WOULD FOLLOW?

SUNIL DHAWAN: THAT'S USUALLY WHAT YOU'RE SUPPOSED TO DO WITH SOP'S IS FOLLOW THE SOP.

MR. SCHENK: AND IF YOU'RE A LAB DIRECTOR WHO IS NOT GIVEN INFORMATION ABOUT DEVIATIONS FROM THE SOP, YOU WOULDN'T KNOW WHETHER THEY WERE FOLLOWING IT OR NOT; IS THAT RIGHT?

SUNIL DHAWAN: YES, I WOULD NOT KNOW.

MR. SCHENK: THANK YOU, YOUR HONOR. NO FURTHER QUESTIONS.

MR. WADE: I BELIEVE I HAVE TWO QUESTIONS.

RECROSS-EXAMINATION BY MR. WADE:

MR. WADE: DR. DHAWAN, YOU WENT INTO THESE INTERACTIONS AND LOOKED AT THESE POLICIES AND LOOKED AT THESE ORG CHARTS AND YOU ASSUMED THAT THESE 30 OR 40 PEOPLE WERE GOING TO WORK EACH AND EVERY DAY ACTING HONESTLY AND IN GOOD FAITH; CORRECT?

SUNIL DHAWAN: THAT IS MY ASSUMPTION WITH ALL OF THE EMPLOYEES THAT WORK FOR ME.

MR. WADE: AND IS THAT YOUR ASSUMPTION AS A HUMAN BEING?

MR. SCHENK: OBJECTION. RELEVANCE.

MR. WADE: WITHDRAWN.

MR. WADE: YOU WERE RELYING UPON PEOPLE TO ACT IN ACCORDANCE WITH THE POLICIES AND TO ACT IN GOOD FAITH; IS THAT RIGHT, SIR?

MR. WADE: AND YOU WERE NOT GIVEN ANY INFORMATION FOR YOU TO SUGGEST THAT YOU SHOULD DO OTHERWISE, CORRECT, SIR?

SUNIL DHAWAN: I WAS NOT GIVEN ANY OTHER INFORMATION, NO.

MR. WADE: THANK YOU.

FURTHER REDIRECT EXAMINATION BY MR. SCHENK:

MR. SCHENK: WHEN YOU WERE MAKING THIS ASSUMPTION THAT THE EMPLOYEES OF THERANOS WERE ACTING A CERTAIN WAY, WERE YOU AT THERANOS? WERE YOU PRESENT TO REACH THAT ASSUMPTION OR TO REACH THAT CONCLUSION?

SUNIL DHAWAN: I WAS NOT THERE. I WAS NOT THERE, BUT MY ASSUMPTION WAS THAT THEY WOULD BE DOING THE WORK THAT THEY WERE SUPPOSED TO DO.

MR. SCHENK: SO YOU WERE SITTING IN YOUR OFFICE --

MR. SCHENK: -- WHEN YOU WERE MAKING THIS ASSUMPTION?

MR. SCHENK: THANK YOU.

MR. WADE: NO FURTHER QUESTIONS.

JUDGE DAVILA: MAY THIS WITNESS BE EXCUSED?

MR. SCHENK: YES, SIR.

MR. WADE: YES, SIR.

JUDGE DAVILA: YOU CAN STAND DOWN, SIR. THANK YOU. I THINK THE GOVERNMENT HAS ANOTHER WITNESS.

MR. BOSTIC: YES, YOUR HONOR.

JUDGE DAVILA: LET ME STATE, WE WERE GOING TO TAKE OUR BREAK, I THINK, AT 11:30, AND I THINK WE WERE GOING TO TAKE ABOUT 30 MINUTES. SHOULD WE TAKE OUR BREAK NOW? IS THAT -- WHY DON'T WE DO THAT. LET'S TAKE OUR 30 MINUTE BREAK NOW, AND THEN WE'LL AT LEAST GET YOUR NEXT WITNESS ON. THANK YOU. SO WE'LL BE IN RECESS, LADIES AND GENTLEMEN. THANK YOU.

ProceduralProc.Hearing on Data-Integrity Questioning

(JURY OUT AT 11:16 A.M.)

JUDGE DAVILA: PLEASE BE SEATED. THANK YOU. THE RECORD SHOULD REFLECT THAT OUR JURY HAS LEFT FOR A RECESS. ALL COUNSEL AND MS. HOLMES IS PRESENT. EXCUSE ME. WE'RE STILL IN SESSION, PLEASE. THANK YOU. MR. WADE.

MR. WADE: YOUR HONOR, I'D LIKE TO RAISE ONE ISSUE THAT HAS NOW COME UP A COUPLE OF TIMES WITH A COUPLE OF WITNESSES AND IT'S CONCERNING TO THE DEFENSE. THE GOVERNMENT HAS ASKED QUESTIONS IN A WAY TO TRY TO CREATE THE IMPRESSION WITH THIS JURY THAT SOME EMPLOYEES ARE FALSIFYING INFORMATION OR FALSIFYING DATA AND ASKING QUESTIONS THAT SUGGEST THAT THERE'S SOME UNDERLYING INTEGRITY ISSUE WITH THE DATA WHEN THERE'S NO EVIDENCE TO THAT EFFECT IN THIS RECORD. AND, AND I'M DEEPLY TROUBLED BY THAT SUGGESTION AND THE IMPLICATION OF THAT. COUNSEL HAS TO HAVE A GOOD FAITH BASIS TO ASK THOSE QUESTIONS AND SHOULD NOT TRY TO CREATE A FALSE IMPRESSION TO THIS JURY.

JUDGE DAVILA: IS THIS RELATED TO MR. SCHENK'S RECENT QUESTIONS?

MR. WADE: SOME OF THE RECENT QUESTIONS RELATING THAT YOU DIDN'T KNOW ABOUT THE DATA, AND THEY WERE ASKED IN A WAY - AND THEY DID IT WITH DR. ROSENDORFF AS WELL -- TO TRY TO CREATE THE IMPRESSION THAT THERE IS SOME UNDERLYING FALSIFICATION OF DATA. THERE'S NOT EVIDENCE OF THAT TO MY KNOWLEDGE IN THIS CASE, BUT IT, IT IS INNUENDO THAT CREATES A FALSE IMPRESSION WITH THE JURY, AND IT'S VERY TROUBLING TO THE DEFENSE.

JUDGE DAVILA: MR. SCHENK, DO YOU WANT TO COMMENT?

MR. SCHENK: I'LL LIMIT MY COMMENTS TO DR. DHAWAN. DR. DHAWAN WAS MAKING A TREMENDOUS NUMBER OF ASSUMPTIONS IN HIS WORK AT THERANOS AND IN HIS ANSWERS TO MR. WADE. WHAT I DID WAS HIGHLIGHT THAT FACT. MR. DHAWAN HAD NO IDEA WHERE THE UNDERLYING DATA CAME FROM, AND THAT WAS THE POINT THAT I HIGHLIGHTED FOR THE JURY. MR. DHAWAN, DR. DHAWAN DID NOT DO ANY FURTHER LOOKING BEYOND THE PAGES TO SEE WHERE THE DATA CAME FROM. SO IT'S A DIFFERENT POINT THAN WHAT MR. WADE IS ACCUSING ME OF DOING. I WASN'T SUGGESTING TO DR. DHAWAN THAT SOMEONE AT THERANOS WAS MANIPULATING DATA. WHAT I WAS SUGGESTING WAS THAT DR. DHAWAN HAD NO IDEA WHERE THE DATA CAME FROM. DR. DHAWAN SIGNED DOCUMENTS, AND HE DIDN'T KNOW WHERE THAT INFORMATION CAME FROM OR THE SOURCE OF THE INFORMATION, AND THAT IS A COMPLETELY APPROPRIATE FACT FOR THE JURY TO WEIGH.

JUDGE DAVILA: YOU KNOW, MR. WADE, THAT'S WHAT I THOUGHT HE WAS DOING. HE WAS -- IT SEEMED TO ME THE EXAMINATION WAS, YOU SIGNED THESE 50, 49 DIFFERENT DOCUMENTS, BUT YOU DIDN'T -- AND YOU RELAYED ON -- AND I THINK YOU DID A GOOD JOB OF SAYING THAT'S COMPLETELY, ACCORDING TO STATUTE, YOU RELIED ON SOMEBODY ELSE'S WORK; AND THEN THE REDIRECT WAS, THAT'S RIGHT, BUT YOU DID NOT FLIP THROUGH THE PAGES AND DO ANY OF THE ANALYSIS YOURSELF. IS THAT IMPROPER?

MR. WADE: I DON'T THINK IT'S IMPROPER TO SAY THAT YOU DIDN'T DO ANY OF THE UNDERLYING ANALYSIS, AND I CAN LOOK AT THE TRANSCRIPT AND WE CAN RAISE THIS AT ANOTHER TIME. BUT THERE HAVE BEEN QUESTIONS, TO ME THE IMPLICATION OF WHICH ARE THAT THERE IS SOME UNDERLYING INTEGRITY ISSUE WITH THE DATA. EXAMINATION OF, WITH RESPECT TO THIS DOCUMENT YOU DON'T KNOW ANYTHING ABOUT THIS DATA, YOU DIDN'T PERFORM THE CALCULATIONS, YOU WEREN'T INVOLVED IN THE DEVELOPMENT WORK, THAT'S ONE THING. THERE HAVE BEEN QUESTIONS WITH A COUPLE OF WITNESS NOW THAT, TO OUR EAR -- AND WE CAN POINT THEM TO THE COURT AND MAYBE SEEK A DIRECTION TO THE JURY ON IT -- THAT CREATE THE IMPRESSION THAT THERE IS SOME UNDERLYING FALSIFICATION OR DATA INTEGRITY ISSUE AND TO MY KNOWLEDGE THERE IS NOT.

JUDGE DAVILA: OKAY. ARE YOU CONCERNED THAT THE GOVERNMENT IN THEIR CLOSING ARGUMENT WILL SO ARGUE? IS THAT YOUR CONCERN?

MR. WADE: I'M CONFIDENT, BASED ON WHAT MR. SCHENK SAID, THAT THEY WON'T. BUT I JUST DON'T WANT THIS CONTINUED ERROR OF THE IMPLICATION BEING THAT THERE'S SOME UNDERLYING INTEGRITY ISSUE BECAUSE I THINK THAT'S -- I THINK IT'S FALSE TO MY KNOWLEDGE. I DON'T THINK THERE'S A GOOD FAITH BASIS TO ASK IT AND I THINK IT CREATES A MISIMPRESSION TO THE JURY.

JUDGE DAVILA: DO YOU INTEND TO SO ARGUE TO THE JURY IN CLOSING ARGUMENT?

MR. SCHENK: IN CLOSING, THE GOVERNMENT IS GOING TO ARGUE THE EVIDENCE. SO WE WILL REVIEW THE TRANSCRIPT AND SEE WHAT THE WITNESSES TESTIFIED TO AND LIMIT ARGUMENT TO THE FACTS THAT HAVE COME IN THROUGH EVIDENCE. I'D LIKE TO SPEND A LITTLE BIT OF TIME ON THE QUESTION OF WHETHER THERE HAVE BEEN STATEMENTS FROM WITNESSES THAT CALL THE INTEGRITY OF THE DATA INTO QUESTION. MY RECOLLECTION IS THAT THERE ACTUALLY HAVE BEEN SOME STATEMENTS FROM WITNESSES THAT HAVE CALLED INTO QUESTION THE INTEGRITY OF THE DATA, WHICH WOULD ALLOW US TO MAKE THE EXACT ARGUMENT THAT MR. WADE IS SUGGESTING WE SHOULDN'T MAKE. SO I DON'T WANT TO COMMIT TO THE COURT RIGHT NOW THAT WE WON'T MAKE THAT ARGUMENT. WE WILL LOOK AT THE TRANSCRIPTS AND SEE WHAT THE EVIDENCE THAT THE JURY HAS HEARD THAT ALLOWS ONE TO CONCLUDE.

JUDGE DAVILA: WHAT ABOUT THIS WITNESS AND THIS WITNESS'S TESTIMONY?

MR. SCHENK: THIS WITNESS WASN'T THERE ENOUGH TO KNOW ABOUT THE INTEGRITY OF THE DATA. WE DEFINITELY DON'T INTEND TO ARGUE THAT THIS WITNESS SUBSTANTIATES A CLAIM NOW THAT THE INTEGRITY OF THE DATA AT THERANOS WAS FALSE. THIS WITNESS PROVES A DIFFERENT POINT.

JUDGE DAVILA: ANYTHING FURTHER YOU'D LIKE TO COMMENT ABOUT MR. WADE'S OBSERVATIONS FROM HIS TEAM ABOUT AT LEAST THIS LAST WITNESS?

MR. SCHENK: NO. THANK YOU.

MR. WADE: WE'LL REST ON THE POSITION FOR NOW. I WANTED TO RAISE IT WITH THE COURT BECAUSE WE'VE SEEN IT IN A COUPLE OF INSTANCES, AND I WOULD SUGGEST THAT IF THAT'S AN AREA WHERE MR. SCHENK BELIEVES IT'S APPROPRIATE TO INQUIRE, THAT WE RAISE THAT ISSUE AND ADDRESS IT BEFORE IT SPILLS OUT IN FRONT OF THE JURY BECAUSE IT, IT HAS OBVIOUSLY VERY PREJUDICIAL IMPLICATIONS FOR OUR CLIENT AND I DON'T THINK IT'S SOMETHING THAT SHOULD POP OUT WILLY NILLY, SO WE WOULD LIKE THE OPPORTUNITY TO BE HEARD ON THAT.

JUDGE DAVILA: WELL, I APPRECIATE YOUR SENSITIVITY TO IT, AND I KNOW THE DEFENSE EARS ARE SOMETIMES FINER TUNED TOWARDS ISSUES AND THINGS. BUT LET ME SAY THAT MY OBSERVATION WAS, AT LEAST WITH THIS WITNESS, THE QUESTIONING WAS, PARTICULARLY ON REDIRECT, SEEMED TO FOCUS ON, YOU DIDN'T DO ANY INDEPENDENT ANALYSIS, YOU RELIED ON THE ASSUMPTIONS THAT YOU MADE, WHICH HE'S ENTITLED TO DO. AS YOU POINTED OUT, THAT'S WHAT A LAB DIRECTOR CAN DO. SO I THINK THERE WAS AN EVEN BALANCE ON THAT. YOU DID THAT ON YOUR CROSS AND RECROSS. SO I DON'T THINK IT WAS AS MUCH OF AN ISSUE WITH THIS WITNESS. PERHAPS THE TUNE CAME UP ON IT WHICH CAUSED YOU TO RISE TO YOUR FEET ON THIS, AND THERE MAY BE WITNESSES, PAST WITNESSES THAT YOU HAD SOME CONCERN ABOUT AS WELL.

MR. WADE: AND THE COURT MAY BE RIGHT, AND I CERTAINLY ACCEPT THAT MR. SCHENK IS SAYING THAT IT WASN'T HIS INTENTION AND I ACCEPT THAT FROM MR. SCHENK. IF THERE'S SOME CONCERN WE SEE IN LOOKING AT THE TRANSCRIPT, WE'LL RERAISE IT. BUT I THINK IT'S GOOD TO HAVE NOTED THIS ISSUE SO WE'RE ALL AWARE OF IT GOING FORWARD.

JUDGE DAVILA: OKAY. GREAT.

MR. SCHENK: THANK YOU.

MR. WADE: THANK YOU.

JUDGE DAVILA: ALL RIGHT. THANKS.

COURT CLERK: COURT IS IN RECESS.

(RECESS FROM 11:23 A.M. UNTIL 11:58 A.M.)